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St. Gabriel Organics ReadiHands

Medically reviewed by Drugs.com. Last updated on Jun 23, 2020.

Dosage form: solution, gel forming, extended release
Ingredients: ALCOHOL 80mL in 100mL
Labeler: MB Solutions
NDC Code: 78139-202

ReadiHands Hand Sanitizer

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):

  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.
  5. Carbomer (in the gel formula, only)
  6. Triisoproanolamine (in the gel formula, only)

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

473 mL NDC: 78139-201-02

ST. GABRIEL ORGANICS READIHANDS 
alcohol solution, gel forming, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78139-202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TRIISOPROPANOLAMINE0.055 mL  in 100 mL
CARBOMER 9400.78 mL  in 100 mL
GLYCERIN1.45 mL  in 100 mL
HYDROGEN PEROXIDE0.125 mL  in 100 mL
WATER17.59 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:78139-202-01473 mL in 1 BOTTLE, PLASTIC
2NDC:78139-202-02710 mL in 1 BOTTLE, PLASTIC
3NDC:78139-202-033785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2020
ST. GABRIEL ORGANICS READIHANDS HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78139-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN1.45 mL  in 100 mL
HYDROGEN PEROXIDE0.125 mL  in 100 mL
WATER18.425 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:78139-201-01710 mL in 1 BOTTLE
2NDC:78139-201-02473 mL in 1 BOTTLE
3NDC:78139-201-033785 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - MB Solutions (117484385)
Registrant - MB Solutions (117484385)
Establishment
NameAddressID/FEIOperations
MB Solutions117484385manufacture(78139-201, 78139-202), pack(78139-201, 78139-202), repack(78139-201, 78139-202), label(78139-201, 78139-202), relabel(78139-201, 78139-202), analysis(78139-201, 78139-202)

 
MB Solutions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.