5253 HAND SANITIZER- ethyl alcohol gel
Innovation Specialties

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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5253 hand sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Hand sanitizer to help decrease bacteria on the skin.

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.

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

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

NPN # 80062390

Made in China For Innovation Line Culver City, CA 90230

Citrus Scent

Packaging

5253 hand sanitizer

5253 HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76138-117(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:76138-117-02	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/16/2018

Labeler - Innovation Specialties (030837314)

Name	Address	ID/FEI	Business Operations
Establishment
Innovation Specialties		030837314	relabel(76138-117) , repack(76138-117)