Label: PEDIADERMICS ECZEMA 3- colloidal oatmeal, dimethicone cream
- NDC Code(s): 76348-580-06
- Packager: Renu Laboratories, Inc.
- 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 17, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients
1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum
- OTHER SAFETY INFORMATION
- QUESTIONS
- STATEMENT OF IDENTITY
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEDIADERMICS ECZEMA 3
colloidal oatmeal, dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-580 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 3.36 g in 168 g OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 0.168 g in 168 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CERAMIDE 1 (UNII: 5THT33P7X7) JOJOBA OIL (UNII: 724GKU717M) RICE BRAN (UNII: R60QEP13IC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) ASCORBYL PALMITATE (UNII: QN83US2B0N) CANDELILLA WAX (UNII: WL0328HX19) PROPANEDIOL (UNII: 5965N8W85T) NIACINAMIDE (UNII: 25X51I8RD4) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) PALMITIC ACID (UNII: 2V16EO95H1) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) CHOLESTEROL (UNII: 97C5T2UQ7J) CERAMIDE NP (UNII: 4370DF050B) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SACCHARIDE ISOMERATE (UNII: W8K377W98I) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CERAMIDE AP (UNII: F1X8L2B00J) EDETATE DISODIUM (UNII: 7FLD91C86K) HEXANEDIOL (UNII: ZIA319275I) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYALURONATE SODIUM (UNII: YSE9PPT4TH) OAT (UNII: Z6J799EAJK) MALTODEXTRIN (UNII: 7CVR7L4A2D) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-580-06 168 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/01/2020 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-580)
