Label: AVEENO CALM PLUS RESTORE SKIN THERAPY BALM- colloidal oatmeal cream

  • NDC Code(s): 69968-0755-2
  • 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 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes
    • eczema
    • poison ivy, oak, or sumac
    • insect bites
  • 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 right away.

  • Directions

    • Apply as needed.
  • Other information

    • Do not use if quality seal is broken or missing.
    • Store at Room Temperature
  • Inactive ingredients

    Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Caprylic/Capric Triglyceride, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Avena Sativa (Oat) Kernel Extract, Sodium Chloride

  • Questions?

    866-428-3366; Outside US, dial collect 215-273-8755

    www.aveeno.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 48g Tube Carton

    NEW!

    Aveeno®

    Calm +

    Restore

    SKIN THERAPY BALM

    Colloidal Oatmeal Skin Protectant

    Sensitive Skin

    Soothes and deeply

    moisturizes to help

    strengthen skin’s

    natural moisture barrier

    STEROID FREE

    FRAGRANCE-FREE

    DERMATOLOGIST RECOMMENDED BRAND

    COLLOIDAL OATMEAL + CERAMIDE

    net wt. 1.7 oz (48 g)

    Aveeno_001

  • INGREDIENTS AND APPEARANCE
    AVEENO CALM PLUS RESTORE SKIN THERAPY BALM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0755
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    CERAMIDE NP (UNII: 4370DF050B)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0755-21 in 1 CARTON07/28/2022
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/28/2022
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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