Label: REMEDY DIMETHICONE MOISTURE BARRIER UNSCENTED- dimethicone cream

  • NDC Code(s): 53329-142-04
  • Packager: Medline Industries, 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 December 3, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient

    Dimethicone 5%

  • Purpose

    Skin Protectant

  • Uses

    Protects from minor skin irritation associated with diaper rash caused from wetness, urine and/or stool. Temporarily protects and helps relieve chapped or cracked skin.

  • 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

    Cleanse skin. Apply cream liberally until entire area is covered. Apply as needed. Protect from freezing. Avoid excessive heat.

  • Inactive ingredients

    aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, cetyl alcohol, cholecalciferol, citric acid, diazolidinyl urea, glycerin, glyceryl stearate se, glycine, helianthus annuus seed oil, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea leaf extract , peg-8, peg-100 stearate, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, rosa canina fruit oil, stearic acid, stearyl alcohol, tetrasodium edta, tocopherol, triethanolamine, water.

  • SPL UNCLASSIFIED SECTION

    Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured for/Fabriqué pour: Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. Imported by/Importé par Medline Canada, Oakville, ON L6L 6R2 www.medline.com 1-800-MEDLINE RJ18WAR

  • Package/Label Principal Display Panel

    Label 118 mL

  • INGREDIENTS AND APPEARANCE
    REMEDY DIMETHICONE MOISTURE BARRIER  UNSCENTED
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCINE (UNII: TE7660XO1C)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    TAURINE (UNII: 1EQV5MLY3D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    HYDROXYTYROSOL (UNII: QEU0NE4O90)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-142-04118 mL in 1 TUBE; Type 0: Not a Combination Product09/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2010
    Labeler - Medline Industries, Inc. (025460908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasatch Labs962452533manufacture(53329-142)