Label: SOOTHE AND COOL INZO BARRIER- dimethicone cream

  • 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 17, 2021

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  • Active ingredient

    Dimethicone 5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects

    • and helps relieve chapped or cracked skin
    • minor cuts, scrapes, and burns
  • Warnings

    For external use only

    Do not use

    on

    • deep or puncture wounds
    • animal bites
    • serious burns

    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

    Keep out of reach of children.

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

  • Directions

    • gently cleanse and dry affected area
    • apply liberally to affected area as needed
  • Inactive ingredients

    Benzethonium Chloride, Cetyl Alcohol, Chloroxylenol, Cholecalciferol, Glyceryl Stearate, Lanolin, Quaternium-15, Retinyl Palmitate, Sodium Cocoyl Isethionate, Sorbitol, Tocopheryl Acetate, Water, Zinc Oxide.

  • Package/Label Principal Display Panel

    Soothe&Cool INZO Barrier Cream

    NDC: 53329-777-04

    Soothe & Cool

    Protect

    INZO Barrier Cream

    with 5% dimethicone

    Invisible Skin Protectant

    Contains Zinc Oxide

    Extra-Strength

    REF MSC095420

    Medline

    4 Fl. Oz. (118.29 mL)

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL INZO BARRIER 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-777
    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
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SORBITOL (UNII: 506T60A25R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-777-04118 mL in 1 TUBE; Type 0: Not a Combination Product04/01/200912/31/2017
    2NDC:53329-777-96144 in 1 BOX04/01/200912/31/2017
    28 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2009
    Labeler - Medline Industries, LP (025460908)
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