FOAMING HAND SANITIZER - benzethonium chloride liquid
Interstate Solutions, 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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Foaming Hand Sanitizer 6575 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

benzethonium chloride USP 0.2%

Drug Facts Box OTC-Indications & Usage Section

For hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box-OTC When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box-OTC Stop Use Section

irritation and redness develop

Drug Facts Box-OTC Keep Out Of Reach Of Children Section

If swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box-OTC Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together until dry

wash hands with soap and water at earliest opportunity

Drug Facts Box-OTC Inactive Ingredient Section

water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, fragrance

Foaming Hand Sanitizer 6575 1 gallon

657541S9830.jpg Foaming Hand Sanitizer 1 gallon image of bottle label

FOAMING HAND SANITIZER
benzethonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50466-575
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description
Packaging
1	NDC:50466-575-10	1000 mL in 1 CARTRIDGE
2	NDC:50466-575-12	1000 mL in 1 BAG
3	NDC:50466-575-13	800 mL in 1 BAG
4	NDC:50466-575-14	3785 mL in 1 BOTTLE, PLASTIC
5	NDC:50466-575-15	946 mL in 1 BOTTLE, PLASTIC
6	NDC:50466-575-16	236 mL in 1 BOTTLE, PLASTIC
7	NDC:50466-575-17	532 mL in 1 BOTTLE, PLASTIC
8	NDC:50466-575-18	50 mL in 1 BOTTLE, PLASTIC
9	NDC:50466-575-24	115 mL in 1 BOTTLE, PLASTIC
10	NDC:50466-575-55	208200 mL in 1 DRUM

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	07/31/2009

Labeler - Interstate Solutions, Inc. (098249477)

Registrant - ABC Compounding Co., Inc. (003284353)

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture