Label: NORML SHIELD- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL

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 March 10, 2022

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  • Active Ingredient

    Dimethicone 4.5%

  • Purpose

    Skin protectant

  • Uses

    Helps prevent and temporarily protects chafed, chapped or cracked skin

  • Warnings

    For external use only.

    Keep out of reach of children.

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

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

    Do not use on
    • deep or puncture wounds
    • animal bites
    • serious burns
  • Directions

    Adults and children 2 years of age and older:  Cleanse affected area.  Allow to dry. Apply MPM NormlShield® liberally. Apply as needed.

    Children under 2 years of age: Consult a physician prior to use.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Aloe barbadensis leaf extract, Cetearyl alcohol and polysorbate 60, Cetyl alcohol, Deionized water, DMDM hydantoin, Glycol stearate, Imidiazolidinyl urea, Isopropyl palmitate, Methylparaben, Mineral oil, PEG-40 hydrogenated castor oil, Propylene glycol, Propylparaben, Stearic acid, Stearyl Alcohol, Tocopheryl acetate, Triethanolamine

  • Package Label

    MP00022 Artwork MPM Normlshield Skin Protectant 4 oz

  • INGREDIENTS AND APPEARANCE
    NORML SHIELD 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE45 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    IMIDUREA (UNII: M629807ATL)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66977-022-04113 g in 1 TUBE; Type 0: Not a Combination Product02/01/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/01/1993
    Labeler - MPM Medical LLC (081241522)
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