5412 HAND SANITIZER by Innovation Specialties 5412 HAND SANITIZER

5412 HAND SANITIZER by

Drug Labeling and Warnings

5412 HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Innovation Specialties. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

5412 HAND SANITIZER- ethyl alcohol gel 
Innovation Specialties

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5412 HAND SANITIZER

Drug Facts

Active ingredient:

Ethyl Alcohol 62%

Purpose

Antiseptic

For handwashing to decrease bacteria on the skin.

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

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 persists for more than 72 hours.

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

Store at room temperature 15° to 30°C (59° to 86°F).

Inactive ingredients:

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

Questions?

HOTLINE # 1-855-755 5346

NPN# 80062390

Made in China For Innovation Line Culver City, CA 90230
Product # CS5412

Packaging

5412 HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-126
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76138-126-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2023	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	03/15/2023	12/01/2023

Labeler - Innovation Specialties (030837314)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(76138-126)

Revised: 10/2023

Document Id: 2a53fd85-b370-4669-a0e2-1c8bedb3d5bf

34390-5

Set id: e85f7d56-3143-48a9-9472-5604dada6fb4

Version: 2

Effective Time: 20231031