NDC Code(s) : 37000-617-26, 37000-617-59, 37000-617-63, 37000-617-70, 37000-617-10, 37000-617-11, 37000-617-16, 37000-617-23, 37000-617-53, 37000-617-22, 37000-617-47, 37000-617-57, 37000-617-12, 37000-617-82, 37000-617-20, 37000-617-40, 37000-617-19, 37000-617-38, 37000-617-21, 37000-617-54, 37000-617-65
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dawn Ultra Antibacterial Hand Chloroxylenol SOAP
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-617
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLOROXYLENOL(UNII: 0F32U78V2Q)
(CHLOROXYLENOL - UNII:0F32U78V2Q)
CHLOROXYLENOL0.3 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
TETRASODIUM GLUTAMATE DIACETATE(UNII: 5EHL50I4MY)
DECETH-8(UNII: 19FQ96EA8Q)
ALCOHOL(UNII: 3K9958V90M)
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PPG-26(UNII: V86KZL3H2Z)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
C9-11 PARETH-8(UNII: 80E6PSE1XL)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-617-26266 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
2NDC:37000-617-59591 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
3NDC:37000-617-63638 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
4NDC:37000-617-70709 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
5NDC:37000-617-101010 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
6NDC:37000-617-111120 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
7NDC:37000-617-161660 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
8NDC:37000-617-23236 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
9NDC:37000-617-53532 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
10NDC:37000-617-222210 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
11NDC:37000-617-47479 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/02/2018
12NDC:37000-617-57573 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/02/2018
13NDC:37000-617-121210 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/02/2018
14NDC:37000-617-82828 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/02/2018
15NDC:37000-617-20207 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/02/2019
16NDC:37000-617-401200 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product04/02/2019
17NDC:37000-617-19192 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/12/2021
18NDC:37000-617-381120 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/12/2021
19NDC:37000-617-21221 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2022
20NDC:37000-617-54532 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2023
21NDC:37000-617-65650 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 07/07/2014

LABELER - The Procter & Gamble Manufacturing Company(004238200)

PRINCIPAL DISPLAY PANEL

DAWN ®
ULTRA

CHLOROXYLENOL ANTIBACTERIAL HAND SOAP


ORANGE SCENT

*VS DAWN NON-CONCENTRATED


DISHWASHING LIQUID

1.12L (1.18 QT) 38 FL OZ

Dawn