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  5. Label Information: Calamine Plus Pramoxine Hcl

FDA Label for Calamine Plus Pramoxine Hcl

View Indications, Usage & Precautions

Table of Contents

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

Calamine Plus Pramoxine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Premier Brands Of America Inc.. 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 Ingredient



Calamine 8%
Pramoxine HCl 1%


Purpose



Skin protectant
External analgesic


Uses



temporarily relieves pain and itching associated with:

  • insect bites
  • rashes
  • minor skin irritations
  • minor cuts
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

​Warnings



​For external use only. ​ Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.


​Flammable:



Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.


​When Using This Product



  • do not get into eyes
  • ask a doctor before  using on children under 2 years of age

Stop Use And Ask A Doctor If



  • conditions worsens
  • symtomps last more than 7 days or clear up and occur again in 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 using
  • adults and children 2 years of age and older
  • cleanse the skin with soap and water
  • let dry before use
  • apply as needed to the affected area, not more than 3 or 4 times daily

​Other Information



store between 20° to 25°C (68° to 77°F)


​Inactive Ingredients



benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate


​Questions?



Call 1-866-964-0939


Principal Display Panel



Premier

Calamine Plus

No-Touch Spray

  • External analgesic & skin protectant
  • Drying action plus itch relief
  • Ideal for poison ivy/oak/sumac, insect bites, minor skin irritations & cuts

    • Shake well before using

    6.0 FL OZ (177mL)

    Net Wt 4.1 OZ (116g)


* Please review the disclaimer below.