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

To help clean hands

Warnings

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

When using this product Avoid contact with eyes. In case of contact flush eyes with water.

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

Directions

Spread on both hands, rub in, let dry.

Inactive Ingredients

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

Questions?

Call 1-855-755-5346

Made in China for Innovation Line Culver City, CA 90230

Citrus Scent

Packaging

sanitzer-5

ANTISEPTIC HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76138-113(NDC:70412-110)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76138-113-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/02/2016

Labeler - Innovation Specialties Inc (030837314)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(76138-113)

Name	Address	ID/FEI	Business Operations
Establishment
Innovation Specialties Inc		030837314	relabel(76138-113) , repack(76138-113)