5413 HAND SANITIZER- ethyl alcohol gel

5413 hand sanitizer by

Drug Labeling and Warnings

5413 hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Innovation Specialties. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient: Ethyl alcohol 62%.

PURPOSE

Purpose: Antiseptic

INDICATIONS & USAGE

For handwashing to decrease bacteria on the skin.

WARNINGS

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

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive ingredients: Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

STORAGE AND HANDLING

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

QUESTIONS

Questions? HOTLINE # 1-855-755 5346 NPN# 80062390

SPL UNCLASSIFIED SECTION

Made in China For Innovation Line Los Angeles,
CA 90066 Product # 5413

Packaging

INGREDIENTS AND APPEARANCE

5413 HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76138-119
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
CARBOXYPOLYMETHYLENE (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: 76138-119-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/25/2018

Labeler - Innovation Specialties (030837314)