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  5. Label Information: Calamine

FDA Label for Calamine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. OTHER
    12. PRINCIPAL DISPLAY PANEL

Calamine Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum


Other



*This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Lotion

DIST. BY MEIJER

DISRIBUTION, INC

GRAND RAPIDS, MN 49544

www.meijer.com

336.002/336AF


Principal Display Panel



NDC 41250-888-30

Compare to Caladryl Lotion

Meijer

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)

image description - mm3

image description - mm3


* Please review the disclaimer below.