Label: DIMETHICONE 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 February 9, 2023

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  • Active ingredient

    Dimethicone 1.2%

  • Purpose

    Skin protectant

  • Uses

    • helps prevent and temporarily protects 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 punture wounds
    • animal bites
    • serious burns
  • When using this product

    do not get into eyes

  • Stop use and ask a doctor if

    • condition wirsens
    • sympton last more then 7 days or clear up and occur again within a few days
  • Keep out of reach of children.

    If swallowed, get medical help ot contact Poison Control right away.

  • Directions 

    • apply as needed
  • Other information

    store between 15°-30°C (59°-86°F)

  • inactive ingredients

    water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, Avena sativa (oat) kernel flour, benzyl alcohol, sodium chloride, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: H-E-B, SAN ANTONIO, TN 78204

    LOT NUMBER: ON PACKAGE

    QUESTIONS? 1-888-593-0593

    MADE IN USA WITH U.S. AND FOREIGN COMPONENTS.

    We hope you are satisfied with this product. 

    If not, we will cheerfully refund your money.

  • Principal panel display

    HILL COUNTRY 

    ESSENTIALS

    Baby Lotion

    WITH COLLOIDAL OATMEAL

    SKIN PROTECTANT

    hypoallergenic

    fRAGRANCE fREE

    Free From Parabens, Phthalates, DYES

    NET WT 8 Oz 

    CONT. NET. 227 g

    image description

  • INGREDIENTS AND APPEARANCE
    DIMETHICONE 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-496
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    distearyldimonium chloride (UNII: OM9573ZX3X)  
    petrolatum (UNII: 4T6H12BN9U)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    cetyl alcohol (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    benzyl alcohol (UNII: LKG8494WBH)  
    sodium chloride (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-496-34227 g in 1 TUBE; Type 0: Not a Combination Product06/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/05/2023
    Labeler - H E B (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-496)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-496)
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