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 Sanear Corporation, 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 a 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 – Sanear 0.057 fl. oz. Pouch

SaniPortables®

Instant Hand

Sanitizer

KILLS 99.9% of GERMS

FRESH SCENT

Enriched with Aloe Vera

0.057 fl. oz. (1.68 ML)

Distributed by

SANEAR Corporation

Matthews, NC 28105

PRINCIPAL DISPLAY PANEL – Sanear 25 count Box

Made in the U.S.A.

NDC: 23638-1111-1

SaniPortables®

Instant Hand Sanitizer

KILLS 99.9% of GERMS

Fresh Scent

Enriched with Aloe Vera

25 packets

Each Packet .057 fl. oz. (1.68 ML)

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 23638-1111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	665 mL  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe (UNII: V5VD430YW9)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23638-1111-1	25 in 1 BOX
1		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	11/21/2011

Labeler - Sanear Corporation (831894980)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE