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Name:Bodycologycoconut Lime
Manufacturer:Landy International
Category:Over-the-counter (OTC) Marketed Drugs


Coconut Lime

BODYCOLOGY COCONUT LIME - triclosan cream 
Landy International

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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Coconut Lime

Active Ingredients               Purpose

Triclosan  0.30%                Antiseptic

Warnings: For external use only. Discontinue use and consult a health care practitioner if irritation develops. Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

USes: for personal hand hygiene to help prevent the spread of certain bacteria

Directions: wet hands. apply palmful to hands. scrub thoroughly for 30 seconds. rinse.

Inactive Ingredients: Water (Aqua), Sodium Laureth Sulfate, Glycerin, Cocamide DEA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Propylene Glycol, Fragrance (Parfum), Triethanolamine, Polyethylene, Disodium EDTA, Aloe Barbadensis (Aloe Vera) Leaf Juice, Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter), Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone. May Contain: Ultramarines (CI 77007), Yellow 5 (CI 19140), Yellow 6 (CI 15985), Yellow 10 (CI 47005), Red 33 (CI 17200), Red 4 (CI 14700), Red 40 (CI 16035), Blue 1 (CI 42090)

image of back label

Bodycology

Coconut Lime Sink Set

177 mL/6fl. oz.

image of front label


BODYCOLOGY  COCONUT LIME
triclosan cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51706-112
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (TRICLOSAN) TRICLOSAN 0.30 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51706-112-02 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (51706-112-01)
1 NDC:51706-112-01 1 mL in 1 BOTTLE This package is contained within the BOX (51706-112-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 01/01/2010

Labeler - Landy International (545291775)
Registrant - Wal-Mart Stores, Inc. (051957769)
Establishment
Name Address ID/FEI Operations
Landy International 545291775 manufacture

Revised: 06/2010 Landy International



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


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