Instant Hand Sanitizer by Safetec of America, Inc. / Safetec of America, Inc

Instant Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

INSTANT HAND SANITIZER- alcohol gel 
Safetec of America, Inc.

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.

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Drug Facts

Active ingredient

Ethyl Alcohol 70

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available
• helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection
• recommended for repeated use

Warnings

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

When using this product

• do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask 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

Directions

• place a small amount into one hand
• spread over both hands and wrist
• rub into the skin until dry
• do not wipe off; no rinsing required

Inactive ingredients

aloe vera, carbomer, red dye, fragrance, purified water, triethanolamine

Principal Display Panel - Container Label

NDC: 61010-8111-0

Safetec

instant
Hand
Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Apple

34,688 fl.oz. (1,026 L) Reorder No. 17394

Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com

Principal Display Panel - Container Label

NDC: 61010-8111-1

Safetec

instant
Hand
Sanitizer

KILLS 99.9% OF GERMS

ENRICHED WITH ALOE VERA

NATIONAL
BREAST
CANCER
FOUNDATION, INC®.

APPLE SCENT

4.0 FL. OZ. (118 ML)

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-8111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	700 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-8111-0	1026 L in 1 CONTAINER; Type 0: Not a Combination Product	02/19/2015	06/04/2015
2	NDC: 61010-8111-1	0.118 L in 1 CONTAINER; Type 0: Not a Combination Product	02/19/2015	06/04/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/19/2015	06/04/2015

Labeler - Safetec of America, Inc. (874965262)

Revised: 12/2019

Document Id: a250e0cd-6b05-491d-b729-528580583394

34390-5

Set id: bfc82054-8b24-430c-b57b-2e4895faac48

Version: 3

Effective Time: 20191206

 

Safetec of America, Inc.