ANTISEPTIC HAND SANITIZER- ethyl alcohol gel 
Innovation Specialties 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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ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

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

Use

For handwashing to decrease bacteria on the skin.

Warnings

Flammable, keep away from fire or flame. For external use only. 

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

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Directions

Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

Inactive ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Store at room temperature 150 to 300C (590 to 860F)

Questions?

HOTLINE # 1-855-755-5346

Made in China for Innovation Line Culver City, CA 90230

Packaging

sanitizer-6

ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76138-113(NDC:70412-110)
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76138-113-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/02/2016
Labeler - Innovation Specialties Inc (030837314)
Establishment
NameAddressID/FEIBusiness Operations
Innovation Specialties Inc030837314relabel(76138-113) , repack(76138-113)

Revised: 12/2022
Document Id: e5e29f5a-2a45-47c9-8a16-fcab01c761a5
Set id: 89af8a07-49cd-4b51-9ca7-016f849d7b70
Version: 5
Effective Time: 20221213
 
Innovation Specialties Inc