Label: CVS CALAMINE PLUS- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • SPL UNCLASSIFIED SECTION

    CVS Calamine Plus

    Drug Facts

  • Active Ingredient

    Calamine 8%

  • Active Ingredient

    Pramoxine HCl 1%

  • Purpose

    Skin Protectant

  • Purpose

    External Analgesic

  • Use

    Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other minor skin irritations.

  • Warnings

    For external use only. Use only as directed.

    When using this product avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

    • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
  • Directions

    • Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth not more than 3 to 4 times daily as needed for comfort.
    • Children under 2 yrs. of age: Consult a doctor.
  • Other Information

    • store at room temperature 15 o – 30 oC (59 o – 85 oF)
  • Inactive Ingredient

    SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

  • PRINCIPAL DISPLAY PANEL

    Calamine
    Plus
    Itch Relief
    6 FL OZ (177 mL)

    PRINCIPAL DISPLAY PANEL Calamine Plus Itch Relief 6 FL OZ (177 mL)

  • INGREDIENTS AND APPEARANCE
    CVS CALAMINE PLUS 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-420-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/01/2008
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(69842-420) , manufacture(69842-420) , pack(69842-420) , label(69842-420)
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