Pure and Protected Hand Sanitizing Liquid: Package Insert and Label Information

PURE AND PROTECTED HAND SANITIZING LIQUID- alcohol solution
UNITERS SPA

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.

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

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

  • 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

Package Label — Principal Display Panel

75 mL label
(click image for full-size original)

1 Gal NDC: 77506-001-26

1 Gal Label Image
(click image for full-size original)
PURE AND PROTECTED HAND SANITIZING LIQUID
alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77506-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 1.45 mL in 100 mL
HYDROGEN PEROXIDE 0.125 mL in 100 mL
WATER 18.43 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77506-001-11 75 mL in 1 BOTTLE, PUMP None
2 NDC:77506-001-26 3780 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/15/2020
Labeler — UNITERS SPA (442983326)
Registrant — Genesis Custom Chemical Blending (080744214)
Establishment
Name Address ID/FEI Operations
Genesis Custom Chemical Blending 080744214 manufacture (77506-001)

Revised: 07/2020 UNITERS SPA

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