Label: EQUATE MEDICATED DRY AND ITCH- dimethicone, menthol lotion

  • 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 March 1, 2017

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  • Active ingredient

    Dimethicone 5%

    Purpose

    Skin Protectant

  • Active ingredient

    Menthol 0.5%

    Purpose

    Anti-itch

  • Uses

    temporarily protects and helps relieve chapped or cracked skin. Temporarily relieves itching associated with:

    • minor skin irritations
    • minor burns
    • rashes due to poison ivy, oak and sumac
    • insect bites
    • sunburn
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness, irritation, swelling or pain persists or increases.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    apply as needed

  • Other information

    store at room temperature.

  • Inactive ingredients

    Water (Aqua), Cetearyl Alcohol, Cetyl Alcohol, Polysorbate 60, Distearyldimonium Chloride, Glycerin, Stearamidopropyl PG-Dimonium Chloride Phosphate, Petrolatum, Aloe Barbadensis Leaf Juice, Stearyl Alcohol, Steareth-2, Steareth-21, Tocopheryl Acetate, Tetrasodium EDTA, Benyzl Alcohol, Iodopropynyl Butylcarbamate, Fragrance (Parfum).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    EQUATE MEDICATED DRY AND ITCH 
    dimethicone, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.05 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-333-15397 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2017
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(49035-333)
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