NDC Code(s) : 42192-108-04
Packager : Acella Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acella Hydrocortisone Acetate - Pramoxine SinglesHYDROCORTISONE ACETATE, PRAMOXINE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-108
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE ACETATE(UNII: 3X7931PO74)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE ACETATE2.5 g in 100 g
PRAMOXINE(UNII: 068X84E056)
(PRAMOXINE - UNII:068X84E056) 		PRAMOXINE1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PETROLATUM(UNII: 4T6H12BN9U)
MINERAL OIL(UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHANOLAMINE LAURYL SULFATE(UNII: E8458C1KAA)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
METHYLPARABEN(UNII: A2I8C7HI9T)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42192-108-0430 in 1 CARTON 08/11/2010
14 g in 1 TUBE, WITH APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/08/2010 05/12/2015

PRINCIPAL DISPLAY PANEL

NDC 42192-108-04                     Rx Only                     Net Wt. 4 g

Hydrocortisone Acetate 2.5% -
Pramoxine HCl 1% Cream

CONTAINS: Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% in a hydrophilic base containing Purified Water, Petrolatum, PEG 40 Stearate, Mineral Oil, Ceresin Wax, Cetostearyl Alcohol, Stearic Acid, TEA-Lauryl Sulfate, Isopropyl Palmitate, Carbomer Homopolymer Type C, Methyl Paraben, Propyl Paraben, Citric Acid, Sodium Citrate and Triethanolamine.

USUAL DOSAGE: Apply to affected area 3 - 4 times daily. See enclosed package insert for full prescribing information.

FOR EXTERNAL USE ONLY. NOT FOR OPTHALMIC USE.

Store at controlled room temperature 15 degree - 30 degree C (59 degree - 86 degree F) Keep tightly closed.

TO OPEN: Remove cap and use point to puncture foil seal.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC                            L697
Alpharetta, GA 30009                                                                           Rev. 0610

PRINCIPAL DISPLAY PANEL

- Helps relieve itching, burning and inflammation.

- 2.5% Hydrocortisone Acetate: Treats inflammation and itching while maintaining an excellent safety profile.

- 1% Pramoxine HCl: Provides fast, soothing relief from pain and itching.

NDC 42192-108-04

Hydrocortisone Acetate 2.5% -
Pramoxine HCl 1% Cream Singles

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

CONTAINS: Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% in a hydrophilic base containing Purified Water, Petrolatum, PEG 40 Stearate, Mineral Oil, Ceresin Wax, Cetostearyl Alcohol, Stearic Acid, TEA-Lauryl Sulfate, Isopropyl Palmitate, Carbomer 940, Methyl Paraben, Propyl Paraben, Citric Acid, Sodium Citrate and Triethanolamine.

USUAL DOSAGE: Apply to affected area 3 - 4 times daily or as directed by a physician. See enclosed package Insert for full prescribing information. Store at 20 degree - 25 degree C (68 degree - 77 degree F) ; excursions permitted to 15 degree - 30 degree C (59 degree - 86 degree F) [see USP Controlled Room Temperature].

Acella Pharmaceuticals, LLC

NDC 42192-108-04
Hydrocortisone Acetate 2.5% -
Pramoxine HCl 1% Cream Singles

DIRECTIONS FOR USE WITH APPLICATOR:
1. Remove the cap and use point to puncture foil seal. Do not peel foil seal away.
2. Attach applicator to the tube.
3. Squeeze the tube to fill applicator and lubricate the tip with cream.
4. Gently insert only the tip of the applicator into the anus and squeeze again to
force contents of tube into the anal canal.
5. Discard empty tube and applicator.

MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009 L701
1-800-541-4902 Rev. 0310

NDC 42192-108-04
Hydrocortisone Acetate 2.5% -
Pramoxine HCl 1% Cream Singles

4 gram Single Use Tubes

Rx Only

Contents: 30 Single Use 4 gram Tubes and Applicators

Acella Pharmaceuticals, LLC

PRINCIPAL DISPLAY PANEL

Acella Tube Label

PRINCIPAL DISPLAY PANEL

Acella Carton