Alcohol Antiseptic 75% Topical Solution SFC02

Antiseptic Hand Rub by

Drug Labeling and Warnings

Antiseptic Hand Rub by is a Otc medication manufactured, distributed, or labeled by ChemQuest Chemicals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC HAND RUB- alcohol liquid 
ChemQuest Chemicals LLC

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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Alcohol Antiseptic 75% Topical Solution SFC02

Drug Facts

Active Ingredient(s)

• Active ingredient[s]: Purpose
• Ethyl Alcohol 75% v/v.: Antiseptic

Purpose

Antiseptic, Hand Rub

Use[s]

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

aloe vera, amp ultra 2000, carbopol ultrez 20, fragrance, tocopheryl acetate (vii E), purified water USP, xiameter OFX 190

Package Label - Principal Display Panel

ANTISEPTIC HAND RUB 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77441-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	7500 L  in 10000 L

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 1342 (UNII: 809Y72KV36)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77441-1001-1	1249.18589 L in 1 CONTAINER; Type 0: Not a Combination Product	06/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/16/2020	08/18/2022

Labeler - ChemQuest Chemicals LLC (835052051)

Registrant - ChemQuest Chemicals LLC (835052051)

Establishment
Name	Address	ID/FEI	Business Operations
ChemQuest Chemicals LLC		835052051	manufacture(77441-1001) , pack(77441-1001) , label(77441-1001)

Revised: 8/2022

Document Id: e68c63f4-c588-1727-e053-2995a90a9ada

34390-5

Set id: a8506aff-a2c4-5ecb-e053-2a95a90ada19

Version: 3

Effective Time: 20220818