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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. DISLCAIMER
    12. ADVERSE REACTIONS
    13. PRINCIPAL DISPLAY PANEL

Calamine Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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%

Pramoxind 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, hydroxypropyl methylcellulose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum


Dislcaimer



This product is not manufactured or distributed by Pfizer Consumer HealthCare, distributor of Caladryl Lotion


Adverse Reactions



DIST. BY TOPCO ASSOCIATES LLC

77111 GROSS POINT RD.

SKOKIE, IL 60077

@TOPCO

QUESTIONS? 1-888-423-0139

[email protected]


Principal Display Panel



TOPCARE

NDC 36800-336-30

MEDICATED

Calamine Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

DRING ACTION

PLUS ITCH RELIEF

For Relief From Pain And Itching Due To:

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

Compare to Caladryl Lotion Active Ingredients

6 FL. OZ. (177 mL)


* Please review the disclaimer below.