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LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CREAM;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 Rochem International Inc, 2 DKSH, 1 Jai Radhe Sales, 2 Nanjing Well Pharmaceutical, 4 Actylis, 1 Aeon Procare, 6 BASF, 2 Corel Pharma Chem, 1 Finar, 4 Gangwal Chemicals, 6 Kerry, 2 Lubrizol Life Science Health, 3 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pluviaendo, 4 Roquette, 7 Seppic, 1 Sigachi Industries, 1 Valens Pharmachem

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Also known as: 515-98-0, Lac-hydrin, Ammonium (+-)-lactate, Ammonium lactate [usan], Azanium;2-hydroxypropanoate, Propanoic acid, 2-hydroxy-, monoammonium salt

Molecular Formula

C₃H₉NO₃

Molecular Weight

107.11 g/mol

InChI Key

RZOBLYBZQXQGFY-UHFFFAOYSA-N

FDA UNII

67M901L9NQ

A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed)

Ammonium lactate is an alpha-Hydroxy Acid.

1 2D Structure

Ammonium Lactate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

azanium;2-hydroxypropanoate

2.1.2 InChI

InChI=1S/C3H6O3.H3N/c1-2(4)3(5)6;/h2,4H,1H3,(H,5,6);1H3

2.1.3 InChI Key

RZOBLYBZQXQGFY-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(C(=O)[O-])O.[NH4+]

2.2 Other Identifiers

2.2.1 UNII

67M901L9NQ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2 Hydroxypropanoic Acid

2. 2 Hydroxypropionic Acid

3. 2-hydroxypropanoic Acid

4. 2-hydroxypropionic Acid

5. D Lactic Acid

6. D-lactic Acid

7. L Lactic Acid

8. L-lactic Acid

9. Lactate

10. Lactate, Ammonium

11. Lactic Acid

12. Propanoic Acid, 2-hydroxy-, (2r)-

13. Propanoic Acid, 2-hydroxy-, (2s)-

14. Sarcolactic Acid

2.3.2 Depositor-Supplied Synonyms

1. 515-98-0

2. Lac-hydrin

3. Ammonium (+-)-lactate

4. Ammonium Lactate [usan]

5. Azanium;2-hydroxypropanoate

6. Propanoic Acid, 2-hydroxy-, Monoammonium Salt

7. Lactate (monoammonium)

8. Lactic Acid Ammonium Salt

9. 2-hydroxypropanoic Acid Monoammonium Salt

10. 67m901l9nq

11. Lac Hydrin

12. Bms-186091

13. Lachydrin

14. Ammonium Lactate (usan)

15. Propanoic Acid, 2-hydroxy-, Ammonium Salt (1:1)

16. Amlactin

17. Laclotion

18. (+/-)-ammonium Lactate; Bms 186091; Lac-hydrin; W 1001-10

19. Kerasal Al

20. Ammonium 2-hydroxypropanoate

21. Einecs 208-214-8

22. 52003-58-4

23. Bms 186091

24. Unii-67m901l9nq

25. Lac-hydrin (tn)

26. Ammonium2-hydroxypropanoate

27. Schembl36407

28. Ammonium Lactate [mi]

29. Ammonium Lactate [inci]

30. Ammonium Lactate [vandf]

31. Ammonium-l-2-hydroxy-propionate

32. Dtxsid3052808

33. Propanoic Acid, 2-hydroxy-, Monoammonium Salt, (+-)-

34. Ammonium (+/-)-lactate

35. Ammonium Lactate [mart.]

36. Lactic Acid Ammonium Salt (inn)

37. Ammonium Lactate [who-dd]

38. Hms3264p05

39. Ammonium Lactate [orange Book]

40. Ccg-213638

41. Db06768

42. Nsc 760427

43. Db-071380

44. D02920

45. 515-98-052003-58-4(replacedby515-98-0)

46. Propanoic Acid, 2-hydroxy-, Monoammonium Salt, (+/-)-

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₃H₉NO₃
Molecular Weight	107.11 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	0
Exact Mass	107.058243149 g/mol
Monoisotopic Mass	107.058243149 g/mol
Topological Polar Surface Area	61.4 Å²
Heavy Atom Count	7
Formal Charge	0
Complexity	53.5
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Ammonium lactate
PubMed Health	Ammonium Lactate (On the skin)
Drug Classes	Antipruritic
Drug Label	Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4.Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light min...
Active Ingredient	Ammonium lactate
Dosage Form	Lotion; Cream
Route	Topical
Strength	eq 12% base
Market Status	Prescription
Company	Watson Labs; Perrigo New York; Taro

2 of 4
Drug Name	Lac-hydrin
PubMed Health	Ammonium Lactate (On the skin)
Drug Classes	Antipruritic
Drug Label	*Lac-Hydrin is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Lac-Hydrin 12% (ammonium lactate) Cream also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light minera...
Active Ingredient	Ammonium lactate
Dosage Form	Cream; Lotion
Route	Topical
Strength	eq 12% base
Market Status	Prescription
Company	Ranbaxy

3 of 4
Drug Name	Ammonium lactate
PubMed Health	Ammonium Lactate (On the skin)
Drug Classes	Antipruritic
Drug Label	Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4.Ingredients: Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, light min...
Active Ingredient	Ammonium lactate
Dosage Form	Lotion; Cream
Route	Topical
Strength	eq 12% base
Market Status	Prescription
Company	Watson Labs; Perrigo New York; Taro

4 of 4
Drug Name	Lac-hydrin
PubMed Health	Ammonium Lactate (On the skin)
Drug Classes	Antipruritic
Drug Label	*Lac-Hydrin is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4-5.4. Lac-Hydrin 12% (ammonium lactate) Cream also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light minera...
Active Ingredient	Ammonium lactate
Dosage Form	Cream; Lotion
Route	Topical
Strength	eq 12% base
Market Status	Prescription
Company	Ranbaxy

4.2 Drug Indication

For the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion.

5.2 FDA Pharmacological Classification

5.2.1 Active Moiety

AMMONIUM LACTATE

5.2.2 FDA UNII

67M901L9NQ

5.2.3 Pharmacological Classes

Acidifying Activity [MoA]

5.3 Absorption, Distribution and Excretion

Absorption

In vitro study of percutaneous absorption of ammonium lactate lotion, 12% using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

5.4 Mechanism of Action

Unknown.

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API Reference Price

[{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683052200,"product":"RM AMMONIUM LACTATE COSMETIC GRADE BATC","address":"NO.201, DEVAVRATA SECTOR 17, VASHI, NAVI MUMBAI - 400705. Contac","city":"NAVI MUMBAI","supplier":"SOLARA ACTIVE PHARMA SCIENCES","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"M S","customerCountry":"UNITED STATES","quantity":"8000.00","actualQuantity":"8000","unit":"KGS","unitRateFc":"13.5","totalValueFC":"102863","currency":"USD","unitRateINR":1058,"date":"03-May-2023","totalValueINR":"8464000","totalValueInUsd":"102863","indian_port":"JNPT","hs_no":"29181190","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"NO.201, DEVAVRATA SECTOR 17, VASHI, NAVI MUMBAI - 400705. Contac, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643567400,"product":"TITANIUM AMMONIUM LACTATE","address":"111, THE GREAT EASTERN GALLERIA,,P LOT NO.20 SECTOR 4 NERUL WEST,","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"POLYGEL ORGANOMETALLIC BRUNEI","supplierCountry":"BRUNEI DARUSSALAM","foreign_port":"MUARA","customer":"POLYGEL INDUSTRIES PRIVATE ","customerCountry":"INDIA","quantity":"1155.00","actualQuantity":"1155","unit":"KGS","unitRateFc":"6.7","totalValueFC":"7763.9","currency":"USD","unitRateINR":"500.8","date":"31-Jan-2022","totalValueINR":"578360.48","totalValueInUsd":"7763.9","indian_port":"JNPT","hs_no":"29319090","bill_no":"7311420","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRUNEI","selfForZScoreResived":"Pharma Grade","supplierPort":"MUARA","supplierAddress":"","customerAddress":"111, THE GREAT EASTERN GALLERIA,,P LOT NO.20 SECTOR 4 NERUL WEST,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655663400,"product":"AMMONIUM LACTATE (TEST LIC : TL\/AZ\/22\/000083) FOR R&D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"49.70","actualQuantity":"49.7","unit":"KGS","unitRateFc":"52","totalValueFC":"2615.4","currency":"USD","unitRateINR":"4105.4","date":"20-Jun-2022","totalValueINR":"204038.38","totalValueInUsd":"2615.4","indian_port":"BOMBAY AIR","hs_no":"29181190","bill_no":"9199513","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690309800,"product":"AMMONIUM LACTATE (TL NO: TL\/AZ\/22\/002141) FOR R&D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"WAVELENGTH PHARMACEUTICALS","supplierCountry":"ISRAEL","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"38.3","totalValueFC":"23210.8","currency":"USD","unitRateINR":"3179.6","date":"26-Jul-2023","totalValueINR":"1907684.121","totalValueInUsd":"23210.8","indian_port":"BOMBAY AIR","hs_no":"29181190","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"}]

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DOSAGE - LOTION;TOPICAL - EQ 12% BASE **Feder...DOSAGE - LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19155

DOSAGE - CREAM;TOPICAL - EQ 12% BASE **Federa...DOSAGE - CREAM;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20508

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ACTIVE PHARMA INGREDIENTS

6 API Suppliers

5 USDMF

3 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

9 FDF Dossiers

8 FDA Orange Book

1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

2 DKSH

1 Jai Radhe Sales

2 Nanjing Well Pharmaceutical

4 Actylis

1 Aeon Procare

6 BASF

2 Corel Pharma Chem

1 Finar

4 Gangwal Chemicals

6 Kerry

2 Lubrizol Life Science Health

3 Microlex e.U

1 Nanjing Bold Chemical

1 Pluviaendo

4 Roquette

7 Seppic

1 Sigachi Industries

1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

17 Topical

14 Solubilizers

10 Film Formers & Plasticizers

9 Parenteral

8 Thickeners and Stabilizers

7 Coating Systems & Additives

6 Co-Processed Excipients

5 Emulsifying Agents

4 Lubricants & Glidants

3 Fillers, Diluents & Binders

3 Surfactant & Foaming Agents

2 API Stability Enhancers

2 Direct Compression

1 Controlled & Modified Release

1 Chewable & Orodispersible Aids

1 Disintegrants & Superdisintegrants

1 Granulation

1 Taste Masking

1 Rheology Modifiers

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

4 Finished Drug Prices

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$ 13

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GLOBAL SALES INFORMATION

50 RELATED EXCIPIENT COMPANIES

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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

LOTION;TOPICAL - EQ 12% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM;TOPICAL - EQ 12% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons