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 September 26, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Calamine 8%

    Pramoxine HCl 1%

  • Purpose

    Skin protectant

    External analgesic

  • Uses

    • 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

    Our Quality Guarantee

    WWW.MEIJER.COM/SATISFACTION

    *This product is not manufactured

    or distributed by Bausch Health US,

    LLC, distributer of Caladryl Lotion

    Calamine Plus Itch Reliever

    DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

  • Principal Panel Display

    NDC 79481-0336-1

    Compare to Caladryl Lotion*

    MEDICATED

    calamine

    lotion

    External Analgesic/Skin Protectant

    Drying Action Plus Itch Relief

    Relieves itching due to insect

    bites, poison oak or ivy, or

    other minor skin irritation

    6 FL OZ (177 mL)

    Empty & Replace Cap

    Plastic Bottle

    how2recycle.info

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine, pramoxine hcl lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0336
    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 HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    benzyl alcohol (UNII: LKG8494WBH)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    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:79481-0336-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/17/2009
    Labeler - Meijer Distribution (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(79481-0336)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(79481-0336)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!