HAND SANITIZER- ethyl alcohol gel 
Orazen Inc

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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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

Inactive Ingredients

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

Other Information

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.

image of blister cardimage of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-001-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/11/2017
Labeler - Orazen Inc (080916640)

Revised: 12/2017
Document Id: 600b618b-183b-18f6-e053-2a91aa0ae7ff
Set id: 600b618b-183a-18f6-e053-2a91aa0ae7ff
Version: 1
Effective Time: 20171210
 
Orazen Inc