V HEALTH Hand Sanitizer: Package Insert and Label Information

V HEALTH HAND SANITIZER- alcohol gel
Barun International 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.

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.

Ethly Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Carbomer, Fragrance, Glycerin, Purified water USP, Triethanolamine

Other information

  • Store below 110°F (43°C). May discolor certain fabrics or surfaces.

Package Label — Principal Display Panel

50mL 3ea Label
(click image for full-size original)

V HEALTH HAND SANITIZER
hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80604-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCERIN
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80604-100-31 3 TUBE in 1 BOX contains a TUBE (80604-100-30)
1 NDC:80604-100-30 50 mL in 1 TUBE This package is contained within the BOX (80604-100-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/16/2020
Labeler — Barun International Inc. (695551980)
Establishment
Name Address ID/FEI Operations
MESO PHARM CO.,LTD 695708527 manufacture (80604-100)

Revised: 09/2020 Barun International Inc.

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