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Instant Hand Sanitizer by PrimeCare + Inc.

Medically reviewed on November 27, 2017

Dosage form: gel
Ingredients: Alcohol 75mL in 100mL
Labeler: PrimeCare + Inc.
NDC Code: 69410-0001

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.

Active Ingredient
75% Ethyl Alcohol

Purpose
Antiseptic

Uses:

  • For hand washing to decrease bacteria/microorganisms on the skin that can cause diseases.
  • Recommended for repeated use.

Warnings:   
◊ For external use only. Avoid contact with broken skin.                                                                                                                                   
◊ Flammable, keep away from heat, flame or fire.                                                                                                                                                                                                                                               ◊ Do not use this product,in or near the eyes.
◊ If eye contact, immediately rinse thoroughly with a lot of water.

  • Stop use and ask a doctor if irritation, redness, or rash develops and persists for more than 3 days.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. Do not inhale or ingest.

Directions:
◊ Wet hands thoroughly with product                                                                                                                                                                         ◊ Rub hands together covering all surfaces until dry quickly without wiping                                                                                                             ◊ Not recommended for infants                                                                                                                                                                                   ◊ Use in children under 6 years of age must be supervised                                                                                                                                  Other Information:
◊ Do not store above 105 F or 39 C
◊ May discolor some fabrics, wood finishes and plastics

Inactive Ingredients: 
Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Hamamelis Virginiana (witchhazel) Leaf Extract, Fragrance

INSTANT HAND SANITIZER  
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69410-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (Alcohol) Alcohol75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
AMINOMETHYLPROPANOL 
ALOE VERA LEAF 
HAMAMELIS VIRGINIANA LEAF WATER 
Packaging
#Item CodePackage Description
1NDC:69410-0001-8240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/26/2014
Labeler - PrimeCare + Inc. (038816798)

 
PrimeCare + Inc.

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Further information

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

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