Label: FASCY MOISTURE BOMB HAND CRE AM MILK- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70991-040-01, 70991-040-02 - Packager: FASCY 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 September 29, 2016
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Glycerin, Cetearyl Alcohol, Mineral Oil, Dipropylene Glycol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Sorbitan Stearate, Sodium Polyacrylate, Ethylhexyl Stearate, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine, Potassium Hydroxide, Trideceth-6, Butyrospermum Parkii (Shea) Butter, Panthenol, Butylene Glycol, Allantoin, Milk Protein Extract, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Ethylhexylglycerin, Disodium EDTA, Methylparaben, Propylparaben, Phenoxyethanol, Fragrance
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- How to use
- How to use
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FASCY MOISTURE BOMB HAND CRE AM MILK
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70991-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 0.8 g in 80 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70991-040-02 1 in 1 CARTON 08/01/2016 1 NDC:70991-040-01 80 mL in 1 TUBE; 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 08/01/2016 Labeler - FASCY Co,.LTD. (689204222) Registrant - FASCY Co,.LTD. (689204222) Establishment Name Address ID/FEI Business Operations FASCY Co,.LTD. 689204222 repack(70991-040) Establishment Name Address ID/FEI Business Operations WELCOS CO.,LTD. 689131584 manufacture(70991-040)