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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. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. REAR LABEL TEXT
    12. PRINCIPAL DISPLAY PANEL

Calamine Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Co. 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


Uses



  • for the temporary relief of pain and itching associated with minor 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 If



  • 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 wash affected area 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


Rear Label Text



Distributed by:  WALGREEN CO.

200 WILMOT RD., DERRFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com  (C) 2016 Walgreen Co.

L001621SC

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

Walgreens pharmacist recommended

Walgreens Pharmacist survey study.  November 2016.

336.002/336AF


Principal Display Panel



Walgreens

Calahist

Medicated Calamine Lotion/External Analgesic/Skin Protectant

Drying action plus itch relief

Compare to Caladryl Lotion active ingredients ††

6 FL OZ (177 mL)

image description - mm01

image description - mm01


* Please review the disclaimer below.