HAND SANITIZER GEL FRAGRANCE FREE- alcohol gel 
Value Products 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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Hand Sanitizer Gel Fragrance Free

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) (70%, 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 (2% v/v).
  3. Hydrogen peroxide (0.13% v/v).
  4. Tert-butyl alcohol (Thickener) (0.4% v/v.)
  5. 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 70% v/v. Purpose: Antiseptic

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

Inactive ingredients

Thickener, glycerin, hydrogen peroxide, water

Purpose

Purpose: Antiseptic

Package Label - Principal Display Panel

Hand Sanitizer Gel Fragrance Free 1 galHand Sanitizer Gel 16oz Label

HAND SANITIZER GEL FRAGRANCE FREE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77715-2675
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.4 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.13 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77715-2675-1473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:77715-2675-23785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Value Products Inc (050514124)
Establishment
NameAddressID/FEIBusiness Operations
Value Products Inc050514124manufacture(77715-2675)

Revised: 1/2022
Document Id: d57a2e65-7971-2d17-e053-2995a90a77be
Set id: ac13ca01-6398-2e50-e053-2a95a90a3404
Version: 4
Effective Time: 20220113
 
Value Products Inc