FOAMY MANGO ANTISEPTIC HAND AND BODY WASH- chloroxylenol soap
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Foamy Mango Antiseptic Hand and Body Wash 6876 Drug facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.3%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

wet hands and forearms
apply 5 milliliters (teaspoonful) or palmful to hands and forearms
scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1

Foamy Mango Antiseptic Hand and Body Wash 6876 Label

product label

Foamy Mango Antiseptic Hand and Body Wash 6876 Label

FOAMY MANGO ANTISEPTIC HAND AND BODY WASH
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47313-876
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ACID RED 1 (UNII: 3365R6427R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47313-876-06	1 in 1 BOX	03/22/2017
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:47313-876-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
3	NDC:47313-876-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
4	NDC:47313-876-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/22/2017
5	NDC:47313-876-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/22/2017
6	NDC:47313-876-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
7	NDC:47313-876-07	700 mL in 1 BAG; Type 0: Not a Combination Product	03/22/2017
8	NDC:47313-876-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/22/2017
9	NDC:47313-876-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/22/2017
10	NDC:47313-876-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
11	NDC:47313-876-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/22/2017
12	NDC:47313-876-13	800 mL in 1 BAG; Type 0: Not a Combination Product	03/22/2017
13	NDC:47313-876-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
14	NDC:47313-876-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
15	NDC:47313-876-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
16	NDC:47313-876-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/22/2017
17	NDC:47313-876-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	03/22/2017
18	NDC:47313-876-08	1 in 1 BOX	03/22/2017
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC:47313-876-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
20	NDC:47313-876-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/22/2017
21	NDC:47313-876-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/22/2017
22	NDC:47313-876-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	03/22/2017
23	NDC:47313-876-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	03/22/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/22/2017	06/21/2023

Labeler - Picolo (151721495)

Registrant - ABC Compounding Co., Inc. (003284353)

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(47313-876)

Revised: 6/2023

Document Id: fea68901-79bb-7f5c-e053-6294a90a147b

Set id: 9034332a-0970-4d74-bbf5-c27b6e61c911

Version: 3

Effective Time: 20230621

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