ALCOHOL ANTISEPTIC- alcohol solution 
J & S Chemical Corporation

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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Drug Facts

Active ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

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 2months 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 glycerin, hydrogen peroxide, purified water USP

Principal Display Panel -

J&S Chemical ™

Alcohol Antiseptic 80%
Topical Solution

Hand Sanitizer

Non-sterile Solution

Manufactured in Compliance to FDA Guidelines

Principal Display Panel
ALCOHOL ANTISEPTIC 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76948-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76948-0005-119 L in 1 PAIL; Type 0: Not a Combination Product03/27/202011/23/2021
2NDC:76948-0005-2208 L in 1 DRUM; Type 0: Not a Combination Product03/27/202011/23/2021
3NDC:76948-0005-31041 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/27/202011/23/2021
4NDC:76948-0005-43.78 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/27/202011/23/2021
5NDC:76948-0005-50.946 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/27/202011/23/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/27/202011/23/2021
Labeler - J & S Chemical Corporation (074551862)

Revised: 11/2021
 
J & S Chemical Corporation