NDC Code(s) : 37000-616-41, 37000-616-59, 37000-616-63, 37000-616-70, 37000-616-82, 37000-616-88, 37000-616-10, 37000-616-11, 37000-616-16, 37000-616-90, 37000-616-22, 37000-616-23, 37000-616-43, 37000-616-53, 37000-616-01, 37000-616-02, 37000-616-03, 37000-616-04, 37000-616-12, 37000-616-47, 37000-616-57, 37000-616-20, 37000-616-40, 37000-616-71, 37000-616-19, 37000-616-45, 37000-616-38, 37000-616-21, 37000-616-54, 37000-616-24, 37000-616-44, 37000-616-65, 37000-616-05, 37000-616-17
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:37000-616
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
C9-11 PARETH-8(UNII: 80E6PSE1XL)
ALCOHOL(UNII: 3K9958V90M)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
D&C GREEN NO. 5(UNII: 8J6RDU8L9X)
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PPG-26(UNII: V86KZL3H2Z)
DECETH-8(UNII: 19FQ96EA8Q)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TETRASODIUM GLUTAMATE DIACETATE(UNII: 5EHL50I4MY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-616-41414 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
2NDC:37000-616-59591 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
3NDC:37000-616-63638 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
4NDC:37000-616-70709 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
5NDC:37000-616-82828 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
6NDC:37000-616-88887 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
7NDC:37000-616-101010 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
8NDC:37000-616-111120 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
9NDC:37000-616-161660 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
10NDC:37000-616-902660 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/07/2014
11NDC:37000-616-222210 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
12NDC:37000-616-23236 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
13NDC:37000-616-43431 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
14NDC:37000-616-53532 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
15NDC:37000-616-012 in 1 PACKAGE 02/10/2017
15638 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
16NDC:37000-616-022 in 1 PACKAGE 02/10/2017
16532 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
17NDC:37000-616-032 in 1 PACKAGE 28/03/2018
17828 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
18NDC:37000-616-042 in 1 PACKAGE 28/03/2018
18573 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/10/2017
19NDC:37000-616-121210 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/06/2018
20NDC:37000-616-47479 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/06/2018
21NDC:37000-616-57573 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/06/2018
22NDC:37000-616-20207 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/02/2019
23NDC:37000-616-401200 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/02/2019
24NDC:37000-616-71709 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/02/2019
25NDC:37000-616-19192 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product30/12/2021
26NDC:37000-616-45458 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product18/11/2021
27NDC:37000-616-381120 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product18/11/2021
28NDC:37000-616-21221 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2022
29NDC:37000-616-54532 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2023
30NDC:37000-616-242070 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2023
31NDC:37000-616-44434 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2023
32NDC:37000-616-65650 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2023
33NDC:37000-616-053 in 1 CELLO PACK 02/07/2023
33650 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/07/2023
34NDC:37000-616-17171 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/01/2024
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 ®
ANTIBACTERIAL

CHLOROXYLENOL ANTIBACTERIAL HAND SOAP

APPLE BLOSSOM SCENT

VS.DAWN NON-CONCENTRATED

DISHWASHING LIQUID

532 mL (1.12 PT) 18 FL OZ

Dawn