Label: DAILY MOISTURIZING- dimethicone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Active ingredient

    Dimethicone 1.3%

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  • Purpose

    Purpose

    Skin Protectant

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  • Uses

    Uses helps prevent and temprarily protects chafed, chapped, cracked or windburned skin.

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  • Warnings

    Warnings

    For external use only

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  • Do not use

    Do not use on deep or puncture wounds, infections, or lacerations. Consult a doctor

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  • When using this product

    Wen using this product keep out of eyes

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  • Stop use

    Stop use and ask a doctor if condition worsens or does not improve within seven days

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  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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  • Directions

    Directions apply liberally as often at necessary

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  • Inactive ingredients

    Inactive ingredients avena sativa (oat)kernel flour, benzyl alcohol, cetyl alcohol, distearyldimonium chloride, glycerin, isopropyl palmitate, petrolaturm, sodium chloride, water

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  • Disclaimer

    This product is not manufactured or distributed by Johnon + Johnson Consumer Products Company, distributor of Aveno Daily Moisturizing Lotion

    Made in the USA with US and foreign components

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  • Adverse Reactions

    DIST. BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT ROADK,

    SKOKIE 60077

    QUESTIONS? 1-888-423-0139 topcare@topco.com

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  • Principal Display Panel

    TopCare

    TONE + TEXTURE

    daily

    moisturizing

    body lotion

    fragrance free

    dermatologist tested

    with natural colloidal oatmeal

    relieves and protects dry skin

    SKIN PROTECTANT

    COMPARE TO AVEENO

    12 FL OZ (354 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    DAILY MOISTURIZING 
    dimethicone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-619
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 13.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    OATMEAL  
    BENZYL ALCOHOL  
    CETYL ALCOHOL  
    DISTEARYLDIMONIUM CHLORIDE  
    GLYCERIN  
    ISOPROPYL PALMITATE  
    SODIUM CHLORIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-619-40 354 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 09/03/2010
    Labeler - TopCo Associates LLC (006935977)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(36800-619)
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