FOAMING ALCOHOL HAND RUB by BRENNTAG MID-SOUTH, INC.

FOAMING ALCOHOL HAND RUB by

Drug Labeling and Warnings

FOAMING ALCOHOL HAND RUB by is a Otc medication manufactured, distributed, or labeled by BRENNTAG MID-SOUTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOAMING ALCOHOL HAND RUB- alcohol liquid 
BRENNTAG MID-SOUTH, INC.

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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Active Ingredient(s)

Alcohol 66% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

2-(perfluorohexyl) ethanol, PEG-10 acrylate/perfluorohexylethyl, purified water

Product Name

FOAMING ALCOHOL HAND RUB 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65353-2450
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)
2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65353-2450-1	18.9 L in 1 PAIL; Type 0: Not a Combination Product	10/19/2020	10/19/2021
2	NDC: 65353-2450-2	1040 L in 1 TANK; Type 0: Not a Combination Product	10/19/2020	10/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/19/2020	10/19/2021

Labeler - BRENNTAG MID-SOUTH, INC. (122625064)

Registrant - BRENNTAG MID-SOUTH, INC. (122625064)

Establishment
Name	Address	ID/FEI	Business Operations
BRENNTAG MID-SOUTH, INC.		122625064	manufacture(65353-2450) , label(65353-2450)

Revised: 1/2022

Document Id: d6c4c84b-9fbe-06d5-e053-2a95a90a11a8

34390-5

Set id: a84d2540-29aa-ebb8-e053-2a95a90ac34e

Version: 9

Effective Time: 20220129