Label: REMEDY NUTRASHIELD- dimethicone cream

  • NDC Code(s): 53329-143-04
  • 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 November 27, 2019

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  • Active ingredient

    Dimethicone 1.0%

  • 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, c12-13 pareth-3, c12-13 pareth-23, carthamus tinctorius (safflower) seed oil, cetyl dimethicone, cholecalciferol, citric acid, cyclopentasiloxane, diazolidinyl urea, dimethicone crosspolymer, dimethiconol, divinyldimethicone/dimethicone copolymer, glycine, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, peg-8, peg/ppg-18/18 dimethicone, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, sodium chloride, tocopherol, water.

  • SPL UNCLASSIFIED SECTION

    Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured in USA for/Fabriqué aux É.-U. 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

  • INGREDIENTS AND APPEARANCE
    REMEDY NUTRASHIELD 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-143-04118 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2010
    Labeler - Medline Industries, Inc. (025460908)