Label: 3CE WHITE MILK CREA M- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60764-125-01, 60764-125-02 - Packager: Nanda Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 14, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Propanediol, Glycerin, Butylene Glycol, Niacinamide, Titanium Dioxide (CI 77891), Cyclopentasiloxane, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Polysorbate 80, Dimethiconol, Sodium PolyacryloyldimethylTaurate, Phenoxyethanol, Hydrogenated Polydecene, Chlorphenesin, Ethylhexylglycerin, Caprylyl Glycol, Betaine, Alcohol, Milk Protein Extract, Trideceth-10, Triethoxycaprylylsilane, Adenosine, Disodium EDTA, Fragrance, Sodium Hyaluronate, Tocopheryl Acetate, Theobroma cacao (Cocoa) seed Butter
- PURPOSE
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CAUTION
CAUTION: 1. If following problems occur upon using the product, stop use immediately, further use may worsen the symptoms. Consult with a dermatologist if necessary. 1) Red spots, swelling, itchiness, irritation, or any other irregularities. 2) If applied area show above symptoms when exposed to direct sunlight. 2. Do not use on areas shows above symptoms when exposed to direct sunlight. 3. Notes on storage and handling 1) Always put the lid back on after use 2) Keep away from reach of children 3) Keep away from high/ low temperature or direct sunlight.
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
3CE WHITE MILK CREA M
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-125 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 0.75 g in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propanediol (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60764-125-02 1 in 1 CARTON 08/20/2016 1 NDC:60764-125-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/20/2016 Labeler - Nanda Co., Ltd (557816075) Registrant - Nanda Co., Ltd (557816075) Establishment Name Address ID/FEI Business Operations Nanda Co., Ltd 557816075 repack(60764-125) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(60764-125)
