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Name:Al Cafoam
Manufacturer:Apple Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Al CaFoam 6917 Drug Facts and Label

AL CAFOAM  - alcohol liquid 
Apple Products, 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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Al CaFoam 6917 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

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

Al CaFoam 6917 1000 ml

../images_otc/al_cafoam_6917M3PE.jpg  Al CaFoam 1000 ml image of cartridge label


AL CAFOAM 
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67147-585
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67147-585-06 1 BAG ( BAG) in 1 BOX contains a BAG
1 800 mL in 1 BAG This package is contained within the BOX (67147-585-06)
2 NDC:67147-585-17 532 mL in 1 BOTTLE, PLASTIC None
3 NDC:67147-585-24 118 mL in 1 BOTTLE, PLASTIC None
4 NDC:67147-585-01 1200 mL in 1 CARTRIDGE None
5 NDC:67147-585-03 350 mL in 1 CARTRIDGE None
6 NDC:67147-585-05 540 mL in 1 BOTTLE, PLASTIC None
7 NDC:67147-585-07 700 mL in 1 BAG None
8 NDC:67147-585-09 2000 mL in 1 CARTRIDGE None
9 NDC:67147-585-10 1000 mL in 1 CARTRIDGE None
10 NDC:67147-585-11 1000 mL in 1 BOTTLE, PLASTIC None
11 NDC:67147-585-12 1000 mL in 1 BAG None
12 NDC:67147-585-13 800 mL in 1 BAG None
13 NDC:67147-585-14 3785 mL in 1 BOTTLE, PLASTIC None
14 NDC:67147-585-15 946 mL in 1 BOTTLE, PLASTIC None
15 NDC:67147-585-28 149 mL in 1 BOTTLE, PLASTIC None
16 NDC:67147-585-27 800 mL in 1 CARTRIDGE None
17 NDC:67147-585-55 208200 mL in 1 DRUM None
18 NDC:67147-585-08 1 BAG ( BAG) in 1 BOX contains a BAG
18 1000 mL in 1 BAG This package is contained within the BOX (67147-585-08)
19 NDC:67147-585-16 236 mL in 1 BOTTLE, PLASTIC None
20 NDC:67147-585-18 50 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 12/01/2010

Labeler - Apple Products, Inc. (965982544)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
Name Address ID/FEI Operations
ABC Compounding Co., Inc. 003284353 manufacture

Revised: 01/2011 Apple Products, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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