Label: DR. OBERON MOMS CARE OIL- dimethicone oil
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Contains inactivated NDC Code(s)
NDC Code(s): 52891-101-01, 52891-101-02 - Packager: Oberon Cosmetic 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 June 11, 2014
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- Official Label (Printer Friendly)
- dimethicone
- Skin protectant
- If swallowed, get medical help or contact a Poison Control Center right away
- skin care for pregnant women
- For external use only
- Apply a thin layer of cream 2-3 times per day. Massage in circular motion.
- water, momordica charantia fruit extract, glycerin, helianthus annuus sunflower seed oil, olea europaea (olive) fruit oil, caprylic capric triglyceride, butylene glycol, dipropylene glycol, glyceryl stearate, polysorbate 60, cetearyl alcohol, glycine soja (soybean) protein, aloe barbadensis leaf extract, sorbitan sesquioleate, PEG-100 stearate, biosacchharide gum-1, glyceryl caprylate, chlorphenesin, panthenol, sodium polyacrylate, hydrogenated polydecene, trideceth-6, carbomer, triethanolamine, magnolia liliflora flower extract, camellia sinensis leaf extract, scutellaria glabra (licorice) root extract, punica granatum fruit extract, allantoin,tocopheryl acetate, dipotassium gylcyrrhizate, adenosine, disodium EDTA, rh-polypeptide-1, bacillus/glutamic acid ferment filtrate, ubiquinone
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INGREDIENTS AND APPEARANCE
DR. OBERON MOMS CARE OIL
dimethicone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52891-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) dimethicone 1.5 in 150 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) MOMORDICA CHARANTIA FRUIT (UNII: UA63Y8U89U) GLYCERIN (UNII: PDC6A3C0OX) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) butylene glycol (UNII: 3XUS85K0RA) dipropylene glycol (UNII: E107L85C40) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) polysorbate 60 (UNII: CAL22UVI4M) SOYBEAN (UNII: L7HT8F1ZOD) ALOE (UNII: V5VD430YW9) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG-100 stearate (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52891-101-02 1 in 1 CARTON 1 NDC:52891-101-01 150 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/01/2014 Labeler - Oberon Cosmetic Co., Ltd. (631155194) Registrant - Oberon Cosmetic Co., Ltd. (631155194) Establishment Name Address ID/FEI Business Operations Oberon Cosmetic Co., Ltd. 631155194 manufacture(52891-101)