Careone Antibacterial Foaming Kitchen

Generic Name: triclosan
Dosage Form: soap

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.

Active Ingredient

Triclosan 0.46%

Purpose

Antibacterial

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Warnings

For external use only.

When using this product

Avoid contact with eyes. If contact occurs, rinse with water.

Stop using this product and ask doctor if

Irritation or redness develops and lasts

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Uses

For washing to decrease bacteria on the skin

Directions

Pump onto dry hands. Work into a lather for 15 seconds or more. Rinse thoroughly

Inactive Ingredients

Water (Aqua), Sodium Xylenesulfonate, Dipropylene Glycol, Glycerin, Sodium PCA, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Polyquaternium-10, Fragrance(Parfum), Disodium Phosphate, Cetyl Alcohol, Aloe barbadensis leaf juice, Citric Acid, Methylparaben, Propylparaben, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

Package Front and Back Labels

care8.jpg
CAREONE ANTIBACTERIAL FOAMING   KITCHEN
triclosan soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-160
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.46 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM POLYSTYRENE SULFONATE  
DIPROPYLENE GLYCOL  
GLYCERIN  
SODIUM PYRROLIDONE CARBOXYLATE  
AMMONIUM LAURYL SULFATE  
COCAMIDOPROPYL BETAINE  
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE  
CETYL ALCOHOL  
ALOE VERA LEAF  
CITRIC ACID MONOHYDRATE  
METHYLPARABEN  
PROPYLPARABEN  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
Packaging
# Item Code Package Description
1 NDC:41520-160-08 222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/04/2010
Labeler - American Sales Company (809183973)
Revised: 01/2010
 
American Sales Company



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