Label: AVEENO SKIN RELIEF OVERNIGHT- dimethicone cream

  • NDC Code(s): 69968-0488-7
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 January 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dimethicone 1.2 %

  • Purpose

    Skin Protectant

  • Uses

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

    Do not use on

    Deep or puncture wounds

    • Animal bites
    • Serious burns.

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

  • Directions

    Apply as needed.

  • Other information

    Store at Room Temperature

  • Inactive ingredients

    water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, benzyl alcohol, avena sativa (oat) kernel oil, steareth-20, methylparaben, sodium chloride, butyrospermum parkii (shea) butter, propylene glycol, chamomilla recutita (matricaria) flower extract, avena sativa (oat) kernel extract

  • Questions?

    Call toll-free 866-428-3366 or 215-273-8755 (collect) or visit www.aveeno.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 207 g Tube Label

    NEW LOOK
    SAME GREAT FORMULA
    Aveeno ®
    SKIN RELIEF
    OVERNIGHT
    cream
    INTENSE MOISTURE
    Dimethicone skin protectant
    Soothes Itchy,
    Very Dry Skin
    Works throughout
    the night
    DERMATOLOGIST
    THERAPEUTIC
    RECOMMENDED BRAND

    fragrance
    free

    with
    TRIPLE OAT COMPLEX
    & NATURAL SHEA BUTTER
    net wt. 7.3 oz (207 g)

    PRINCIPAL DISPLAY PANEL - 207 g Tube Label
  • INGREDIENTS AND APPEARANCE
    AVEENO SKIN RELIEF OVERNIGHT 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0488
    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)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OAT (UNII: Z6J799EAJK)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0488-7207 g in 1 TUBE; Type 0: Not a Combination Product05/22/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/22/2007
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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