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Hand Sanitizer by Orazen Inc

Medically reviewed on December 10, 2017

Dosage form: gel
Ingredients: ALCOHOL 62mL in 100mL
Labeler: Orazen Inc
NDC Code: 71927-001

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:
Ethyl Alcohol 62% w/w

Purpose

Antiseptic

Warnings

Flammable, keep away from fire or flame.

For external use only.

Stop use and ask a doctor if irritation and redness develops and persists for more that 72 hours.

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

Directions

  • Wet hands thoroughly with product
  • Briskly rub hands together until dry
  • Supervise children in the use of this product

Inactive Ingredients

water, carbomer, fragrance, triethanoamine, glycerin, propylene glycol, isopropyl alcohol, isopropyl myristate, tocopheryl acetate, aloe vera extract

Other Information

  • Store at room temperature 15 to 30C (59 to 86F)
  • May discolor certain fabrics

Use

For hand washing to decrease bacteria on the skin

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE 
.ALPHA.-TOCOPHEROL ACETATE 
ISOPROPYL ALCOHOL 
WATER 
ALOE VERA LEAF 
GLYCERIN 
PROPYLENE GLYCOL 
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:71927-001-0130 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/11/2017
Labeler - Orazen Inc (080916640)

 
Orazen Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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