RediHands SANITIZER GEL FORMULATION

ReadiHands SANITIZER by

Drug Labeling and Warnings

ReadiHands SANITIZER by is a Otc medication manufactured, distributed, or labeled by St. Gabriel Organics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

READIHANDS SANITIZER- alcohol solution 
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.

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RediHands SANITIZER GEL FORMULATION

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. Carbomer.

c. Glycerol (1.45% v/v).

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

e. Triisopropanolamine.

d. Sterile distilled water or boiled cold water.

This product is a Gel - a semisolid dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion. A gel may contain suspended particles.

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 SANITIZER

GEL FORMULA

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 Solution
Antiseptic Hand Sanitizer
Non-sterile Solution

0.473 L (473 mL) 

image description

READIHANDS SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 86033-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E) 0.78 L  in 100 L
GLYCERIN (UNII: PDC6A3C0OX) 1.45 L  in 100 L
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L  in 100 L
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) 0.0555 L  in 100 L
WATER (UNII: 059QF0KO0R) 17.5895 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 86033-202-010.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/202005/27/2021
2NDC: 86033-202-020.710 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/202005/27/2021
3NDC: 86033-202-033.785 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/202005/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/202005/27/2021
Labeler - St. Gabriel Organics (941759656)

Revised: 7/2021
 

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