RediHands SANITIZING WIPES Fresh Lemon Scent

RediHands SANITIZING WIPES Fresh Lemon Scent by

Drug Labeling and Warnings

RediHands SANITIZING WIPES Fresh Lemon Scent by is a Otc medication manufactured, distributed, or labeled by St. Gabriel Organics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REDIHANDS SANITIZING WIPES FRESH LEMON SCENT- alcohol cloth 
St. Gabriel Organics

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.

----------

RediHands SANITIZING WIPES Fresh Lemon Scent

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

a. 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.

b. Fragrance (0.3% v/v)

c. Glycerol (1.45% v/v).

d. Hydrogen peroxide (0.125% v/v).

e. Sterile distilled water or boiled cold water.

This product is a liquid applied to a nonwoven cloth.

Active Ingredient(s)

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitzer

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

carbomer, glycerin, hydrogen peroxide, triisopropanolamine, water

Package Label - Principal Display Panel

RediHands SANITIZING WIPES

Fresh Lemon Scent

Helps reduce bacteria that potentially can cause disease.

KILLS 99.9% OF GERMS*

*Effective at eliminating 99.9% of illness-causing germs.

80% Alcohol

Made in USA

Alcohol Antiseptic 80%
Topical Non-sterile Solution
Antiseptic Hand Sanitizer

80 Wipes

ReadiHands_Wipes_4sep2020.jpg

REDIHANDS SANITIZING WIPES FRESH LEMON SCENT 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 86033-203
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.3 L  in 100 L
GLYCERIN (UNII: PDC6A3C0OX)	1.45 L  in 100 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 L  in 100 L
WATER (UNII: 059QF0KO0R)	18.125 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86033-203-01	0.296 L in 1 CANISTER; Type 0: Not a Combination Product	09/23/2020	05/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/23/2020	05/27/2021

Labeler - St. Gabriel Organics (941759656)

Revised: 7/2021

Document Id: c09f382d-ad0c-4043-97dc-7d3d5a2a774f

34390-5

Set id: 87b22581-f66a-478a-83fc-12653a333099

Version: 2

Effective Time: 20210708