Label: CALAMINE- calamine, pramoxine hcl lotion

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

Drug Label Information

Updated July 31, 2024

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  • Active ingredients

    Calamine 8%

    Pramoxine HCl 1%

  • Purpose

    Skin protectant

    External analgesic

  • Use

    • for the temporary relief of pain and itching associated with minot skin irritations and 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

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor

    • condition worsens
    • symptoms last more than 7 days or clean 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

    • shake well
    • before applying was affected are of skin

    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 - do not use, ask a doctor

  • Other information

    store at room temperature (59°-77°F)

  • Inactive ingredients

    alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC,

    ELK GROVE VILLAGE, IL 60007

    TOPCO VIJa0622 QUESTIONS? 1-888-423-0139

    topcare@topco.com www.topcarebrand.com

    Quality Guaranteed

    Visit here for more information: http://topbrnds.com/4901jm

    *This product is not manufactured or distributed by Bausch Health US, LLC, distributer of Caladryl Lotion Calamine Plus Itch Reliever

  • principal display panel

    TopCare Health

    COMPARE TO CALADRYL LOTION ACTIVE INGREDIENTS*

    NDC 76162-336-30

    MEDICATED

    Calamine Lotion

    EXTERANAL ANALGESIC/SKIN PROTECTANT

    For Relief from Pain & Itching Due to:

    • Poison Ivy, Oak & Sumac
    • Insect Bites
    • Minor Skin Irritations

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine, pramoxine hcl lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-336-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/21/2009
    Labeler - Topco associates LLC (006935977)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(76162-336)
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