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

Label

ANTISEPTIC HAND RUB 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77441-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7500 L  in 10000 L
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77441-1001-11249.18589 L in 1 CONTAINER; Type 0: Not a Combination Product06/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/16/202008/18/2022
Labeler - ChemQuest Chemicals LLC (835052051)
Registrant - ChemQuest Chemicals LLC (835052051)
Establishment
NameAddressID/FEIBusiness Operations
ChemQuest Chemicals LLC835052051manufacture(77441-1001) , pack(77441-1001) , label(77441-1001)

Revised: 8/2022