REDICARE HAND SANITIZER- alcohol liquid

Redicare Hand Sanitizer by

Drug Labeling and Warnings

Redicare Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

Ethyl Alcohol 80% v/v. Purpose: Antibacterial Agent

Purpose

Uses

For personal use for hand sanitizing to decrease bacteria on skin.

Warnings

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

Do not use

• internally
• on face or near eyes - in case of eye contact, flush thoroughly
• near heat/sparks/open flames
• on children less than 2 months old.

ASK DOCTOR

Ask a doctor if you have redness or irritation that appears and lasts

KEEP OUT OF REACH OF CHILDREN

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

Directions

Apply a small amount to palm. Briskly rub, covering hands with product. Allow to dry. Children should always be supervised when using this product.

Inactive ingredients

glycerin, hydrogen peroxide, purified water

Package Label - Principal Display Panel

8 fl oz - 237 mL NDC: 71105-222-02

PRINCIPAL DISPLAY PANEL

2 fl. oz.

INGREDIENTS AND APPEARANCE

REDICARE HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-222
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71105-222-02	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/15/2020
2	NDC: 71105-222-08	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/15/2020

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	label(71105-222)