HAND SANITIZER- alcohol liquid 
CHARLES JACQUIN ET CIE, 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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

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

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.

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

Other information

1000ml NDC 77690-919-19

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375ml NDC 77690-919-18

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200ml GlassBottle NDC 77690-919-12 and 200ml PlasticBottle NDC 77690-919-16

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Inactive ingredients

1000 ml NDC 77690-919-19

1000ml_front_label

1000ml_back_label375 ml NDC 77690-919-18

375ml_front

375ml_back

200 ml glass bottle NDC 77690-919-12 and 200 ml plastic bottle NDC 77690-919-16

200ml_front

200ml_back

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77690-919
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77690-919-191000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:77690-919-18375 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
3NDC:77690-919-12200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
4NDC:77690-919-16200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Labeler - CHARLES JACQUIN ET CIE, INC. (002293918)
Establishment
NameAddressID/FEIBusiness Operations
CHARLES JACQUIN ET CIE, INC.002293918manufacture(77690-919)

Revised: 5/2020
Document Id: a571df31-0142-6d7a-e053-2995a90ad82f
Set id: a5773685-29d2-dca1-e053-2a95a90a0f63
Version: 1
Effective Time: 20200512
 
CHARLES JACQUIN ET CIE, INC.