Label: SKIN RELIEF- lotion 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 September 19, 2023

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  • Active Ingredient

    Dimethicone 1.2%

  • Purpose

    Skin protectant

  • Uses

    • Helps prevent and temporarily protects chafed, chapped or cracked skin.
    • Helps protect from the drying effects of wind and cold weather.
  • 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

    Apply as necessary

  • Inactive Ingredients

    Water (Aqua), Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Sodium Chloride.

  • Questions or Comments?

    1-800-925-4733

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    SKIN RELIEF 
    lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1200 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    OATMEAL (UNII: 8PI54V663Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OAT (UNII: Z6J799EAJK)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5995-18511 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/11/2023
    Labeler - Walgreen (008965063)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(0363-5995)
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