Label: AVEENO- 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 May 21, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone 1.25%

  • Purposes

    Skin Protectant

  • Uses

    • Helps prevent and temporarily protects chafed, chapped, or cracked skin
  • Warnings

    For external use only.

    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 immediately.

  • Directions

    • Apply liberally as often as needed.
  • Inactive ingredients

    Avena Sativa (Oat) Kernel flour, Benzyl Alcohol, Cetyl Alcohol, Distearyldimonium Chloride, Glycerin, Isopropyl Palmitate, Petrolatum, Sodium Chloride, Water

  • Questions?

    1-877-288-2525 or visit www.Aveeno.com

  • PRINCIPAL DISPLAY PANEL

    dermatologist
    recommended

    Aveeno®
    ACTIVE NATURALS®

    Daily Moisturizing
    LOTION
    dimethicone skin protectant

    clinically proven to
    relieve dry skin

    moisturizes for 24 hours
    fragrance free

    with
    natural colloidal oatmeal

    18 fl. oz. (532 mL)

    NDC 54868-5875-0

    image of package label




    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma           74146
  • INGREDIENTS AND APPEARANCE
    AVEENO 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5875(NDC:58232-9907)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone13 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Distearyldimonium Chloride (UNII: OM9573ZX3X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5875-0532 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/31/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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