Label: DR. OBERON DIAPER RASH BABY CREAM- zinc oxide, dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52891-104-01, 52891-104-02 - 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 26, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- For external use onlyWhen using this productDo not get into eyesStop use and ask a doctor ifCondition worsensSymptoms last more than 7 days or clear up and occur within a few days.
- Zinc Oxide (5%)Dimethicone (1%)
- Skin protectant
- Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
- Helps treat and prevent diaper rash Protects chafed skin due to diaper rash Helps seal out wetness
- 1. Change wet or soiled diapers promptly2. Clean the diaper area3. Allow to dry4. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.
- Water, Butylene glycol, Olea europaea (olive) fruit oil, Cetearyl olivate, Sorbitan olivate, Glycerin, Caprylic/capic triglyceride, Beeswax, Cetearyl alcohol, Sodium hyaluronate, Butyrospermum parikli (shea) butter, Theobroma cacao (cocoa) seed butter, Trehalose, Limnanthes alba (meadowfoam) seed oil,, Betula platyphylla japonica juice, glyceryl caprylate, glycerin, portulaca oleracea extract, centella asiatica extract, polyconum cuspidatum root extract, scutellaria baicalensis root extract, camellia sinesis leaf extract, glycyrrhiza glabra (licorice) root extract, Chamomilla ecutita (matricaria) flower extract, Rosmarinus officinalis (rosemary) leaf extract, P-anisic acid, Xanthan gum, Lactic acid, Tocopheryl acetate, Punica granatum fruit extract, Allantoin, Panthenol, Dipotassium glycyrrhizate, Fragrance
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INGREDIENTS AND APPEARANCE
DR. OBERON DIAPER RASH BABY CREAM
zinc oxide, dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52891-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.75 g in 15 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.15 g in 15 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene glycol (UNII: 3XUS85K0RA) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) Cetearyl olivate (UNII: 58B69Q84JO) Sorbitan olivate (UNII: MDL271E3GR) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) YELLOW WAX (UNII: 2ZA36H0S2V) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) SHEA BUTTER (UNII: K49155WL9Y) THEOBROMA CACAO WHOLE (UNII: EB048G1S9J) Trehalose (UNII: B8WCK70T7I) LIMNANTHES ALBA WHOLE (UNII: DKY81513ER) BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K) glyceryl caprylate (UNII: TM2TZD4G4A) glycerin (UNII: PDC6A3C0OX) PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2) CENTELLA ASIATICA (UNII: 7M867G6T1U) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M) P-ANISIC ACID (UNII: 4SB6Y7DMM3) XANTHAN GUM (UNII: TTV12P4NEE) LACTIC ACID (UNII: 33X04XA5AT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E) Allantoin (UNII: 344S277G0Z) Panthenol (UNII: WV9CM0O67Z) DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52891-104-02 1 in 1 CARTON 1 NDC:52891-104-01 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/26/2014 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(52891-104)