Label: REMEDY SKIN REPAIR- dimethicone cream
- NDC Code(s): 53329-161-04, 53329-161-13, 53329-161-23, 53329-161-96
- Packager: Medline Industries, LP
- 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 October 25, 2022
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- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Canola Oil, Cetyl Alcohol, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Diazolidinyl Urea, Glycerin, Glyceryl Stearate SE, Glycine, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Methylsulfonylmethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-8, PEG-100 Stearate, Propylene Glycol, Propylparaben, Pyridoxine HCl, Retinyl Palmitate, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopherol, Triethanolamine, Vanillin, Water, Zea Mays Oil.
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
REMEDY SKIN REPAIR
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) CANOLA OIL (UNII: 331KBJ17RK) CETYL ALCOHOL (UNII: 936JST6JCN) CHOLECALCIFEROL (UNII: 1C6V77QF41) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ORANGE OIL (UNII: AKN3KSD11B) MANDARIN OIL (UNII: NJO720F72R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCINE (UNII: TE7660XO1C) PROLINE (UNII: 9DLQ4CIU6V) TAURINE (UNII: 1EQV5MLY3D) METHYLPARABEN (UNII: A2I8C7HI9T) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ACETYLCYSTEINE (UNII: WYQ7N0BPYC) NIACINAMIDE (UNII: 25X51I8RD4) OLIVE OIL (UNII: 6UYK2W1W1E) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TROLAMINE (UNII: 9O3K93S3TK) VANILLIN (UNII: CHI530446X) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-161-23 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/01/2008 05/11/2024 2 NDC:53329-161-13 59 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2008 05/11/2024 3 NDC:53329-161-04 118 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2008 05/11/2024 4 NDC:53329-161-96 144 in 1 CARTON 08/01/2008 05/11/2024 4 4 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2008 05/11/2024 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
