5257 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.

----------

5257 Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl alcohol 62%.

Purpose

Antiseptic

For handwashing to 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

Made in China for Innovation Line Culver City, CA 90230

NPN# 80062390

Packaging

5257 Hand Sanitizer

5257 HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76138-121(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:76138-121-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2019	07/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/11/2019	07/31/2023

Labeler - Innovation Specialties (030837314)

Name	Address	ID/FEI	Business Operations
Establishment
Innovation Specialties		030837314	relabel(76138-121) , repack(76138-121)

Revised: 2/2023

Document Id: 27ebc85f-2173-42fb-8864-31b15425a9af

Set id: c62f5213-3450-44c2-982c-1969a443d7ee

Version: 3

Effective Time: 20230214

Innovation Specialties