FIRST AID ONLY INSTANT HAND SANITIZER- alcohol gel
Acme United Corporation

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.

----------

First Aid Only Instant Hand Sanitizer Gel

Active Ingredient(s)

Ethyl Alcohol 70% w/w

Purpose

Antimicrobial

Use

.hand sanitizer to help reduce microbes on the skin

Warnings

Flammable. Keep away from fire or flame For external use only

When using this product, do not use in or near the eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if redness or irritation develops 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

put enough gel in your palm to cover your hands and rub hand together rapidly until dry

■ children under 6 years of age should be supervised when using this product

Other information

■ store below 110°F {43°C)

■ may discolor certain fabrics or surfaces

Inactive ingredients

carbomer, fragrance, glycerin, propylene glycol, silicone, triethanolamine, water (aqua)

Package Label - Principal Display Panel

Bottle Label 60 mL NDC: 0924-0401-01

FIRST AID ONLY INSTANT HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-0401(NDC:28691-0700)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	77 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON (UNII: Z4152N8IUI)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-0401-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2020
2	NDC:0924-0401-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2020
3	NDC:0924-0401-03	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2020
4	NDC:0924-0401-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2020
5	NDC:0924-0401-05	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2020
6	NDC:0924-0401-06	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/09/2020

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-0401) , repack(0924-0401)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-0401) , repack(0924-0401)