Label: CALAMINE- nanz relieve calamine lotion lotion

  • NDC Code(s): 83254-076-00, 83254-076-01, 83254-076-02, 83254-076-05, view more
    83254-076-06, 83254-076-10, 83254-076-15, 83254-076-25, 83254-076-50
  • Packager: 1201258 Ontario Inc. O/A Nanz Pharma
  • 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 May 18, 2023

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  • Active Ingredients

    Calamine 7.6% and Zinc Oxide 7.6%

  • Purpose

    Skin protectant

  • Uses:

    For temporary relief of skin irritations and itching caused by insect bites, sunburn, poison ivy, sumac, and poison oak.

  • Caution & Warnings:

    For external use only.Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if symptoms worsen or last for more than 7 days.When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    Do not use on broken skin.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

    Children under 6 months of age: Consult a doctor before use.

  • Inactive ingredients

    Glycerin, Bentonite, Calcium Hydroxide, Water

  • Other information:

    Store at room temperature 13-30C (50-86F)

  • PRINCIPAL DISPLAY PANEL

    NDC: 83254-075

    Labels for all sizes Nanz Relieve Calamine Lotion Label

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    nanz relieve calamine lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83254-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED7.6 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    BENTONITE (UNII: A3N5ZCN45C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83254-076-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    2NDC:83254-076-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    3NDC:83254-076-25225 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    4NDC:83254-076-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    5NDC:83254-076-15150 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    6NDC:83254-076-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    7NDC:83254-076-50250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    8NDC:83254-076-0050 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    9NDC:83254-076-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01605/05/2023
    Labeler - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
    Registrant - 1201258 Ontario Inc. O/A Nanz Pharma (256906595)
    Establishment
    NameAddressID/FEIBusiness Operations
    1201258 Ontario Inc. O/A Nanz Pharma256906595manufacture(83254-076) , pack(83254-076) , label(83254-076)
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