Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- isopropyl alcohol liquid
RACK Furniture Group for Children, LLC.

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. Isopropyl Alcohol (75%, 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.

Isopropyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

For hand washing to decrease bacteria on the skin. Good for repeated use.

Warnings

External use only. Keep out of reach of children. Flammable.

Keep out of reach of children.

Directions

  • Briskly rub generous amount on hands and rub together until dry.

Inactive ingredients

Water, distilled

Package Label — Principal Display Panel

59.2mL NDC: 80428-109-01

2 OZ Bottle
(click image for full-size original)

118.3mL NDC: 80428-209-02

4 OZ Bottle
(click image for full-size original)
HAND SANITIZER
isopropyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80428-109
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 in 100
Inactive Ingredients
Ingredient Name Strength
WATER 30
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80428-109-01 59.2 LIQUID in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020 03/30/2049
HAND SANITIZER
isopropyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80428-209
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 in 100
Inactive Ingredients
Ingredient Name Strength
WATER 30
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80428-209-02 118.3 LIQUID in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020 03/30/2049
Labeler — RACK Furniture Group for Children, LLC. (080196774)
Registrant — RACK Furniture Group for Children, LLC. (080196774)
Establishment
Name Address ID/FEI Operations
RACK Furniture Group for Children, LLC. 080196774 repack (80428-109)

Revised: 03/2020 RACK Furniture Group for Children, LLC.

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