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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
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. DISCLAIMER
    12. ADVERSE REACTION
    13. PRINCIPAL DISPLAY PANEL

Calamine Product Label

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


Disclaimer



*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl Lotion Calamine Plus Itch Reliever.


Adverse Reaction



Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION GUARANTEED

100% QC


Principal Display Panel



NDC 83324-053-06

QC

QUALITY CHOICE

*Compare to CALADRYL

Medicated

Calamine

Lotion

External Analgesic/Skin Protectant

For relief from pain and itching due to:

Poison Ivy, Poison Sumac, Insect Bites, Poison Oak & Minor Skin Irritations

6 FL OZ (177 mL)

image description - mm01

image description - mm01


* Please review the disclaimer below.