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NDC 21749-0999-42 ACQUAINT Antibacterial Foam Handwash 0.05 mg/mL Details

ACQUAINT Antibacterial Foam Handwash 0.05 mg/mL

ACQUAINT Antibacterial Foam Handwash is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GOJO Industries, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	21749-0999
Product ID	21749-999_62af6556-f448-48f0-8926-b989bbf643ab
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	ACQUAINT Antibacterial Foam Handwash
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLOROXYLENOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.05
Active Ingredient Units	mg/mL
Substance Name	CHLOROXYLENOL
Labeler Name	GOJO Industries, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2022-12-31

Package

Package Images

NDC 21749-0999-42 (21749099942)

Pricing Information	N/A
NDC Package Code	21749-999-42
Billing NDC	21749099942
Package	1250 mL in 1 BOTTLE (21749-999-42)
Marketing Start Date	2019-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 280f754b-25a5-4106-bbe7-da3f1c0d1056 Details

Active ingredient

Chloroxylenol 0.5%

Purpose

Antimicrobial

Use

Handwash to help decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands
Apply product and thoroughly cover hands with lather
Rinse well and dry hands completely

Inactive ingredients

Water (Aqua), Alcohol, Sodium Laureth Sulfate, Disodium Cocoamphodiacetate, Glycerin, Isopropyl Alcohol, Lactic Acid, Fragrance (Parfum), Red 4 (CI 14700), Yellow 6 (CI 15985)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACQUAINT ANTIBACTERIAL FOAM HANDWASH

chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21749-999
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	.05 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTIC ACID (UNII: 33X04XA5AT)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21749-999-42	1250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/15/2019

Labeler - GOJO Industries, Inc. (004162038)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		036424534	manufacture(21749-999)

Name	Address	ID/FEI	Business Operations
Establishment
GOJO Industries, Inc.		088312414	label(21749-999) , pack(21749-999)

Revised: 12/2019

Document Id: 62af6556-f448-48f0-8926-b989bbf643ab

Set id: 280f754b-25a5-4106-bbe7-da3f1c0d1056

Version: 2

Effective Time: 20191227