FIRST AID DIRECT HAND SANITIZER- hand sanitizer gel

First Aid Direct Hand Sanitizer by

Drug Labeling and Warnings

First Aid Direct Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Ethyl alcohol 66.5%

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• for handwashing to decrease bacteria on skin without soap and water
• recommended for repeated use

WARNINGS

Warnings

For external use only. 

Flammable, keep away from fire or flame. 

Do not use in eyes. If this happens, rinse 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 ingested get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

• wet hands & wrists thoroughly with product and allow to dry without wiping
• children under 6 years of age should be supervised while using this product

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments?

1-800-327-2704 M-F 8 am - 5 pm

Principal Display Panel

HAND SANITIZER GEL

Ethyl Alcohol 66.5%

Fresh Scent Instant Hand Sanitizer with Aloe Vera

SEE BOX OR DRUG FACTS CARD FOR COMPLETE WARNINGS

USES For hand washing to decrease bateria on skin without soap and water. Recommended for repeated use. 

DO NOT USE IF PACKET IS TORN OR OPEN. 

NET WT. 1/32 oz. (0.9g)

TEAR HERE

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
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: 42961-123-02	10 in 1 BAG	07/20/2023
1	NDC: 42961-123-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/20/2023

Labeler - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	manufacture(42961-123)