Label: DR. OBERON MOMS CARE CREAM- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52891-100-01, 52891-100-02 - 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 May 29, 2014
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- Official Label (Printer Friendly)
- dr. oberon mom's care cream package label
- Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
- Dimethicone (1%)-------Skin protectant
- Skin protectant
- skin care for pregnant women
- Warnings For external use only Do not use on Deep or puncture wounds, Animal bites, Serious burns When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor If your skin is red, inflamed, itchy or irritated.§ Condition worsens
- Apply a thin layer of cream 2-3 times per day. Massage in circular motion
- Water, momordica charantia fruit extract, caprylic/capric triglyceride, butylene glycol, glycerin, olea europaea (olive) fruit oil, butyrospermum park II (shea butter), ipropylene glycol, beeswax, glyceryl stearate, polysorbate 60, cetearyl alcohol, sorbitan sesquioleate, PEG-100 stearate, sodium polyacrylate, glyceryl, caprylate, proprylene glycol, hydrogenated polydecene, phellinus linteus extract, oryza sativa (rice) bran extract, chlorphenesin, xanthan gum, magnolia liliflora flower extract, allantoin, tocopheryl acetate, RH-polypeptide-1, Glycerin, sodium phosphate,disodium phosphate,RH-oligopeptide-1,punica granatum fruit extract, Adenosine, trideceth-6, sodium hyaluronate, ubiquinone
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INGREDIENTS AND APPEARANCE
DR. OBERON MOMS CARE CREAM
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52891-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) MOMORDICA CHARANTIA FRUIT (UNII: UA63Y8U89U) butylene glycol (UNII: 3XUS85K0RA) glycerin (UNII: PDC6A3C0OX) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) SHEA BUTTER (UNII: K49155WL9Y) dipropylene glycol (UNII: E107L85C40) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) polysorbate 60 (UNII: CAL22UVI4M) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG-100 stearate (UNII: YD01N1999R) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) glyceryl caprylate (UNII: TM2TZD4G4A) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) PHELLINUS LINTEUS WHOLE (UNII: YVO92B1UCA) ORYZA SATIVA WHOLE (UNII: 84IVV0906Z) chlorphenesin (UNII: I670DAL4SZ) xanthan gum (UNII: TTV12P4NEE) MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH) allantoin (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52891-100-02 1 in 1 PACKAGE 1 NDC:52891-100-01 100 g in 1 PACKAGE 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(52891-100)