INSTANT HAND SANITIZER- alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by APEX Sanitation, LLC, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on skin without soap and water.

Warnings

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

Keep out of reach of children.

Do not use in eyes, if this happens, rinse thoroughly with water.

Stop use, ask doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

Directions

• wet hands & wrists thoroughly with product and allow to dry without wiping

Inactive ingredients

aloe vera, carbomer, D&C green # 5, D&C yellow # 10, fragrance, purified water, triethanolamine

PRINCIPAL DISPLAY PANEL – Pouch

NDC: 57685-7110-0

APEX

ANTISEPTIC

Instant Hand

Sanitizer

Fresh Scent
with Aloe Vera

0.0570 fl.oz. (1.68 mL)

MFD for APEX SANITATION, LLC.

Detroit, MI 48228 800-281-1878

www.ApexAntiseptic.com

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57685-7110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	540.26 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe (UNII: V5VD430YW9)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
d&c green no. 5 (UNII: 8J6RDU8L9X)
d&c yellow no. 10 (UNII: 35SW5USQ3G)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57685-7110-0	0.00168 L in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/27/2013

Labeler - APEX Sanitation, LLC (078776562)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(57685-7110)