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NDC 43374-0876-12 Sani Foam Mango Antiseptic Hand and Body Wash 3 mg/mL Details

Sani Foam Mango Antiseptic Hand and Body Wash 3 mg/mL

Sani Foam Mango Antiseptic Hand and Body Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Delta Foremost Chemical Corporation. The primary component is CHLOROXYLENOL.

Product Information

NDC	43374-0876
Product ID	43374-876_6f5d8f4b-775a-4593-8657-f60c1077eb63
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sani Foam Mango Antiseptic Hand and Body Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLOROXYLENOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	mg/mL
Substance Name	CHLOROXYLENOL
Labeler Name	Delta Foremost Chemical Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 43374-0876-12 (43374087612)

Pricing Information	N/A
NDC Package Code	43374-876-12
Billing NDC	43374087612
Package	1000 mL in 1 BAG (43374-876-12)
Marketing Start Date	2018-06-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ce1b2056-8553-4ac1-985f-9327de60a0c2 Details

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

Sani Foam Mango Antiseptic Hand and Body Wash 6876

INGREDIENTS AND APPEARANCE

SANI FOAM MANGO ANTISEPTIC HAND AND BODY WASH

chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43374-876
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:43374-876-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	06/21/2018
2	NDC:43374-876-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/2018
3	NDC:43374-876-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/21/2018
4	NDC:43374-876-13	800 mL in 1 BAG; Type 0: Not a Combination Product	06/21/2018
5	NDC:43374-876-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/21/2018
6	NDC:43374-876-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	06/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/21/2018

Labeler - Delta Foremost Chemical Corporation (007039910)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(43374-876)

Revised: 12/2018

Document Id: 6f5d8f4b-775a-4593-8657-f60c1077eb63

Set id: ce1b2056-8553-4ac1-985f-9327de60a0c2

Version: 3

Effective Time: 20181227