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Name:Bodycologywhite Gardenia
Manufacturer:Landy International
Category:Over-the-counter (OTC) Marketed Drugs


White Gardenia

BODYCOLOGY WHITE GARDENIA - triclosan gel 
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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White Gardenia

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 of contact a Poison Control Center right away

Uses: For personal hand hygiene to help prevent the spread of certain bacteria

Directions: Wet hands, apply palm 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

White Gardenia Sink Set

Anti-Bacterial Scrubbing Hand Soap

177 mL/ 6 fl.oz.

Hand and Body Lotion

170g / 6oz.

image of front label


BODYCOLOGY  WHITE GARDENIA
triclosan gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51706-115
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:51706-115-02 1 BOTTLE, PUMP ( BOTTLE) in 1 KIT contains a BOTTLE, PUMP (51706-115-01)
1 NDC:51706-115-01 177 mL in 1 BOTTLE, PUMP This package is contained within the KIT (51706-115-02)

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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