Hand sanitizer liquid

Active ingredient(s)

Alcohol 80% 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

Otc - when using section

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.

Otc - stop use section

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

Otc - keep out of reach of children section

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)

Ingredients and appearance - Product information

Hand sanitizer liquid- Alcohol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 75160-002
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Alcohol ( UNII: 3K9958V90M)( Alcohol - UNII: 3K9958V90M ) 80 mLin 100 mL

Inactive Ingredients

Ingredient Name Code
Denatonium benzoate ( UNII: 4YK5Z54AT2)
Glycerin ( UNII: PDC6A3C0OX)
Hydrogen peroxide ( UNII: BBX060AN9V)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 75160-002-06 177.441mL in 1 BOTTLE, PLASTIC 2020/05/25

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part333A USA 2020/05/25

Labeler - Bendistillery Inc( 017937462)

Establishment

Name ID/FEI Business Operations
Bendistillery Inc 017937462 manufacture( 75160-002)