Label: VITAMIN B5 ESSENCE- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51346-436-01, 51346-436-02 - Packager: NATURE REPUBLIC 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 January 19, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water, Cyclopentasiloxane, Glycerin, Panthenol, Niacinamide, Pentylene Glycol, Polyglycerin-3, Trehalose, Dipropylene Glycol, Xylitol, Sodium Polyacrylate, Butylene Glycol, Propanediol, Boron Nitride, Phenoxyethanol, PEG/PPG-18/18 Dimethicone, Pyrus Malus (Apple) Fruit Water, Lecithin, Ethylhexyl Stearate, Sodium Hyaluronate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Trideceth-6, Madecassoside, Polyglutamic Acid
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VITAMIN B5 ESSENCE
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51346-436 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 1.57 g in 35 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:51346-436-02 1 in 1 CARTON 12/01/2016 1 NDC:51346-436-01 35 mL in 1 BOTTLE, PUMP; 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 12/01/2016 Labeler - NATURE REPUBLIC CO., LTD. (631172020) Registrant - NATURE REPUBLIC CO., LTD. (631172020) Establishment Name Address ID/FEI Business Operations NATURE REPUBLIC CO., LTD. 631172020 relabel(51346-436) Establishment Name Address ID/FEI Business Operations Cosmax, Inc 689049693 manufacture(51346-436)