Label: SAFEWAY- dimethicone lotion

  • 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 December 15, 2011

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  • ACTIVE INGREDIENT

    DIMETHICONE 1.25%

  • PURPOSE

    SKIN PROTECTANT

  • USES

    TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

  • WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

  • STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS. IF CONDITION WORSENS OR SYMPTOMS LAST FOR MORE THAN SEVEN DAYS OR CLEARS UP AND RE-OCCURS WITHIN A FEW DAYS.

  • KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    ADULTS AND CHILDREN OVER 2 YEARS. APPLY AS NEEDED.

  • INACTIVE INGREDIENTS:

    WATER (AQUA), GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PETROLATUM, ISOPROPYL PALMITATE, CETYL ALCOHOL, AVENA SATIVA (OAT) KERNEL FLOUR, BENZYL ALCOHOL, SODIUM CHLORIDE, DMDM HYDANTOIN, METHYLPARABEN, PROPYLPARABEN.

  • LABEL COPY


    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    SAFEWAY 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.25 mL  in 100 mL
    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)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-320-18532 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/03/2012
    Labeler - SAFEWAY INC. (009137209)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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