INSTANT FOAM HAND SANITIZER- alcohol liquid

Instant Foam Hand Sanitizer by

Drug Labeling and Warnings

Instant Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dixie Packing & Seal Company, ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62% v/v

Drug Facts Box OTC-Purpose Section

Antiseptic

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

FLAMMABLE, keep away from fire and flames

For external use only

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 and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, DEA-C8-18 perfluoroalkylethyl phosphate, propylene glycol, fragrance

Instant Foam Hand Sanitizer 6585 50ml

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INGREDIENTS AND APPEARANCE

INSTANT FOAM HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50491-855
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50491-855-06	1 in 1 BOX
1		800 mL in 1 BAG
2	NDC: 50491-855-17	532 mL in 1 BOTTLE, PLASTIC
3	NDC: 50491-855-24	118 mL in 1 BOTTLE, PLASTIC
4	NDC: 50491-855-01	1200 mL in 1 CARTRIDGE
5	NDC: 50491-855-03	350 mL in 1 CARTRIDGE
6	NDC: 50491-855-05	540 mL in 1 BOTTLE, PLASTIC
7	NDC: 50491-855-07	700 mL in 1 BAG
8	NDC: 50491-855-09	2000 mL in 1 CARTRIDGE
9	NDC: 50491-855-10	1000 mL in 1 CARTRIDGE
10	NDC: 50491-855-11	1000 mL in 1 BOTTLE, PLASTIC
11	NDC: 50491-855-12	1000 mL in 1 BAG
12	NDC: 50491-855-13	800 mL in 1 BAG
13	NDC: 50491-855-14	3785 mL in 1 BOTTLE, PLASTIC
14	NDC: 50491-855-15	946 mL in 1 BOTTLE, PLASTIC
15	NDC: 50491-855-28	149 mL in 1 BOTTLE, PLASTIC
16	NDC: 50491-855-27	800 mL in 1 CARTRIDGE
17	NDC: 50491-855-55	208200 mL in 1 DRUM
18	NDC: 50491-855-08	1 in 1 BOX
18		1000 mL in 1 BAG
19	NDC: 50491-855-16	236 mL in 1 BOTTLE, PLASTIC
20	NDC: 50491-855-18	50 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/01/2009

Labeler - Dixie Packing & Seal Company (798812889)

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(50491-855)