Label: AVEENO ANTI-ITCH CONCENTRATED- zinc oxide, ferric oxide red, and pramoxine hydrochloride lotion

  • NDC Code(s): 69968-0475-4
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Calamine 3%Skin Protectant
    Pramoxine HCl 1%External Analgesic
  • Uses

    • For temporary relief of pain and itching associated with:
      • minor burns
      • sunburn
      • minor cuts
      • scrapes
      • insect bites
      • minor skin irritations
      • rashes due to poison ivy, poison oak, or poison sumac
    • Dries the oozing and weeping of poison:
      • ivy
      • oak
      • sumac
  • Warnings

    For external use only.

    Do not use

    • on wounds or damaged skin

    When using this product

    • do not get into eyes
    • do not bandage tightly

    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 right away.

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: ask a doctor.
  • Other information

    • Store at Room Temperature
  • Inactive ingredients

    Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Camphor, Methylparaben, Sodium Chloride, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernal Flour, Avena Sativa (Oat) Kernel Extract

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    Dermatologist
    Recommended

    Aveeno ®

    Anti-Itch
    CONCENTRATED LOTION
    External Analgesic/Skin Protectant

    Fast-Acting,
    Soothing Itch Relief of:
    Poison Ivy/Oak/Sumac,
    Insect Bites

    Soothes Chicken Pox Rash
    and Allergic Itches

    Aveeno ®
    Dermatologist recommended
    for over 65 years

    with Triple
    Oat Complex

    4 fl. oz. (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    AVEENO ANTI-ITCH CONCENTRATED 
    zinc oxide, ferric oxide red, and pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0475
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE29.4 mg  in 1 mL
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.6 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    OATMEAL (UNII: 8PI54V663Y)  
    OAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0475-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2019
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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