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.

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First Aid Only Instant Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

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

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, ask a doctor if 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

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

Questions 1.800.835.2263

Box Label

FIRST AID ONLY INSTANT HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0924-0450(NDC:61010-1112)
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALOE (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
FRAGRANCE 13576 (UNII: 5EM498GW35)
CARBOMER 980 (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0924-0450-00	0.034 L in 1 POUCH; Type 0: Not a Combination Product	08/11/2021
2	NDC:0924-0450-01	10 in 1 BOX	08/18/2023
2		0.034 L in 1 POUCH; Type 0: Not a Combination Product
3	NDC:0924-0450-02	20 in 1 BOX	08/18/2023
3		0.034 L in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/11/2021

Labeler - Acme United Corporation (001180207)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		045924339	relabel(0924-0450) , repack(0924-0450)

Name	Address	ID/FEI	Business Operations
Establishment
Acme United Corporation		080119599	relabel(0924-0450) , repack(0924-0450)