Label: REMEDY SKIN REPAIR- dimethicone cream

  • NDC Code(s): 53329-140-04, 53329-140-23
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • Active ingredient

    Dimethicone 1.5%

  • Purpose

    Skin Protectant

  • Uses

    temporarily protects and helps relieve chapped or cracked skin. Beneficial for face, hands, body and legs.

  • Warnings

    For External Use Only.

    Do not use

    on deep or puncture wounds, on animal bites, or serious burns

    When using this product

    do not get into eyes.

    Stop use and ask a doctor if

    condition worsens, symptoms last for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply cream liberally until entire area is covered
    • apply as needed
  • Other information

    • protect from freezing, avoid excessive heat
  • Inactive ingredients

    aloe barbadensis leafe juice, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol citric acid, diazolidinyl urea, glycerin, glyceryl stearate SE, glycine, hydroxytyrosol, L-proline, L-taurine, methylparaben, methylsulfonylmethane, A-acetyl-L-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-100 stearate, PEG-8, propylene glycol, propylparaben, pyridoxine HCl, retinyl palmitate, stearic acid, stearyl alcohol, tetrasodium EDTA, tocopherol, triethanolamine, water

  • Manufacturing Information

    Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc.

    Manufactured for: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of domestic and imported materials

    www.medline.com

    1-800-MEDLINE

    REF: MSC094842UNSC

    RB18WAR

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    REMEDY SKIN REPAIR 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-140-04118 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2010
    2NDC:53329-140-23946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/01/2010
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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