Label: BODYCOLOGY WHITE GARDENIA- triclosan gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51706-115-01, 51706-115-02 - Packager: Landy International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 29, 2010
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ACTIVE INGREDIENT
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)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BODYCOLOGY WHITE GARDENIA
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51706-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.30 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51706-115-02 1 in 1 KIT 1 NDC:51706-115-01 177 mL in 1 BOTTLE, PUMP 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 Business Operations Landy International 545291775 manufacture