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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 United Natural Foods, Inc. Dba Unfi. 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 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



  • 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


Other



*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company distributor of Caladryl Lotion

Distributed by Supervalu Inc.

Eden Prairie, MN 55344 USA

Contact us at 1-877-932-7948 or www.sumpervalu-ourownbrands.com


Principal Display Panel



Compare to Caladryl Lotion active ingredient*

EQUALINE

medicated calamine lotion

external analgesic

skin protectant

drying action plus itch relief

6 FL OZ (177 mL)

image description - mm4

image description - mm4


* Please review the disclaimer below.