Label: REMEDY NUTRASHIELD- dimethicone lotion

  • NDC Code(s): 53329-157-02, 53329-157-04, 53329-157-13, 53329-157-77, view more
    53329-157-96
  • 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 August 17, 2023

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  • Active ingredient

    Dimethicone 1.0%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent 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
    • on serious burns

    When using this product

    • do not get into eyes

    Stop use and ask a doctor

    • 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 liberally as needed.
  • Other information

    • Protect from freezing. Avoid excessive heat.
  • Inactive ingredients

    aloe barbadensis leaf juice, ascorbic acid, ascorbyl palmitate, c12-c13 pareth-3, c12-c13 pareth-23, carthamus tinctorius seed oil, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis peel oil, citrus grandis peel oil, citrus tangerina peel oil, cyclopentasiloxane, diazolidinyl urea, dimethicone crosspolymer, dimethiconol,
    divinyldimethicone/dimethicone copolymer, ethyl vanillin, glycine, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea fruit oil, olea europaea 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 for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. www.medline.com 1-800-MEDLINE RJ18WAR

  • Package Labels

    Label 04Label 13

    Label PacketLabel Box

  • INGREDIENTS AND APPEARANCE
    REMEDY NUTRASHIELD 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-157
    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)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCINE (UNII: TE7660XO1C)  
    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)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-157-1359 mL in 1 TUBE; Type 0: Not a Combination Product10/10/201812/06/2023
    2NDC:53329-157-04118 mL in 1 TUBE; Type 0: Not a Combination Product10/10/201812/06/2023
    3NDC:53329-157-96144 in 1 BOX10/10/201803/31/2024
    34 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:53329-157-774 mL in 1 PACKET; Type 0: Not a Combination Product06/01/200503/31/2024
    5NDC:53329-157-023 in 1 BAG07/01/2021
    5NDC:53329-157-04118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2005
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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