Label: DR. OBERON NATURAL BABY- allantoin lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 52891-103-01, 52891-103-02 - 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 29, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Allantoin
- Skin protectant
- Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
- For soothing baby’s skin or sensitive skin
- 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. Store at room temperature
- Apply a thin layer of cream and massage in circular motion.
- Water, Glycerin, Caprylic/capric triglyceride, Cetearyl olivate, Sorbitan olivate, Sodium hyaluronate, TrehaloseBetaine, Phenyl trimethicone Squalane, Zanthoxylum piperitum fruit extract, Pulsatilla koreana extract, Usnea barbata (lichen) extract, Carbomer, Arginine, Caprylyl glycol, Panthenol, Ceramide 3, Glycyrrhiza glabra (licorice) root extract, Camellia sinesis leaf extract, Rosmarinus officinalis (rosemary) leaf extract, Centella asiatica extract, Chamomilla recutita (matricaria) flower extract, Scutellaria baicalensis root extract, Polygonum cuspidatum root extract, Butylene glycol, Punica granatum fruit extract, P-anisic acid, Dipotassium glycyrrhizate, Xanthan gum, Lavandula angustifolia (lavender) oil
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. OBERON NATURAL BABY
allantoin lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52891-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 in 50 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) Trehalose (UNII: B8WCK70T7I) Betaine (UNII: 3SCV180C9W) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) Squalane (UNII: GW89575KF9) ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251) PULSATILLA KOREANA WHOLE (UNII: 5R35881OBK) USNEA BARBATA (UNII: D6DVA9TCAP) CARBOMER 1342 (UNII: 809Y72KV36) Arginine (UNII: 94ZLA3W45F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Panthenol (UNII: WV9CM0O67Z) CERAMIDE 3 (UNII: 4370DF050B) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O) CENTELLA ASIATICA (UNII: 7M867G6T1U) MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E) P-anisic acid (UNII: 4SB6Y7DMM3) DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360) XANTHAN GUM (UNII: TTV12P4NEE) LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52891-103-02 1 in 1 CARTON 1 NDC:52891-103-01 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/21/2014 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(52891-103)
