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Name:Anti-bacterial Deep Cleansing Hand Caramel Apple
Manufacturer:Bath & Body Works, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

ANTI-BACTERIAL DEEP CLEANSING HAND  CARAMEL APPLE - triclosan soap 
Bath & Body Works, 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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DRUG FACTS

ACTIVE INGREDIENT

Triclosan 0.3%

PURPOSE

Antibacterial

USE

Handwashing to decrease bacteria on skin

WARNINGS

For external use only.

WHEN USING THIS PRODUCT

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

STOP USE AND ASK A DOCTOR

if irritation and redness develop.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

  • Wet hands, work into a rich lather
  • Rinse well

INACTIVE INGREDIENTS

Water (Aqua, Eau), TEA-Lauryl Sulfate, Propylene Glycol, Alcohol Denat., Lauramide DEA, Fragrance (Parfum), Honey Extract (Mel, Extrait de miel), Bambusa Vulgaris Leaf/Stem Extract, Cocos Nucifera (Coconut) Fruit Extract,  Aloe Barbadensis Leaf Juice, Olea Europaea (Olive) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Panthenol, Retinyl Palmitate, Tocopheryl Acetate, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyethylene, Disodium Laureth Sulfosuccinate, Acacia Senegal Gum, Gelatin, Glycerin, Xanthan Gum, Tetrasodium EDTA, Benzophenone-4,  Methylchloroisothiazolinone, Methylisothiazolinone, Ultramarines (CI 77007), Yellow 5 (CI 19140), Red 33 (CI 17200), Yellow 6 (CI 15985), Blue 1 (CI 42090).

COMPANY INFORMATION

Bath & Body Works, Distr.
Reynoldsburg, Ohio 43068
1-800-395-1001
www.bathandbodyworks.com


PRODUCT PACKAGING

Front Label
Back Label

ANTI-BACTERIAL DEEP CLEANSING HAND   CARAMEL APPLE
triclosan soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62670-3758
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 3 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
TROLAMINE LAURYL SULFATE  
PROPYLENE GLYCOL  
LAURIC DIETHANOLAMIDE  
HONEY  
BAMBUSA VULGARIS TOP  
COCONUT  
ALOE VERA LEAF  
BLACK OLIVE  
SHEA BUTTER  
PANTHENOL  
VITAMIN A PALMITATE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
TROLAMINE  
DISODIUM LAURETH SULFOSUCCINATE  
ACACIA  
GELATIN  
GLYCERIN  
XANTHAN GUM  
EDETATE SODIUM  
SULISOBENZONE  
METHYLCHLOROISOTHIAZOLINONE  
METHYLISOTHIAZOLINONE  
FD&C YELLOW NO. 5  
D&C RED NO. 33  
FD&C YELLOW NO. 6  
FD&C BLUE NO. 1  
ALCOHOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62670-3758-3 242 g in 1 BOTTLE, PUMP None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 01/06/2011

Labeler - Bath & Body Works, Inc. (878952845)

Revised: 01/2011 Bath & Body Works, Inc.



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


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