Label: AVEENO CALM PLUS RESTORE ITCH RELIEF BALM- pramoxine hydrochloride cream

  • NDC Code(s): 69968-0796-4
  • 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 5, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pramoxine HCl (0.5%)

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of itching associated with:

    • minor skin irritations
  • Warnings

    For external use only.

    When using this product

    • Avoid contact with the eyes.

    ​​Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for 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, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Aloe Barbadensis Leaf Extract, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

  • 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 - 113g Tube Carton

    NEW

    Aveeno®

    Calm +

    Restore

    ITCH RELIEF

    BALM

    Pramoxine HCl external analgesic

    Sensitive,

    Delicate Skin

    Instantly soothes

    and helps relieve itch

    FRAGRANCE FREE

    DERMATOLOGIST RECOMMENDED BRAND

    PREBIOTIC OAT, ALOE, PRO-VIT B5

    net wt.

    4 OZ (113 g)

    Aveeno_01

  • INGREDIENTS AND APPEARANCE
    AVEENO CALM PLUS RESTORE ITCH RELIEF BALM 
    pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0796
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE5 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)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OATMEAL (UNII: 8PI54V663Y)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OAT (UNII: Z6J799EAJK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0796-41 in 1 CARTON07/03/2023
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/03/2023
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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