Label: CALAMINE- calamine, pramoxine hcl lotion

  • 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 August 24, 2022

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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 finalpart34705/21/2009
    Labeler - Topco associates LLC (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(76162-336)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(76162-336)
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