FDA Label for Calamine Plus Pramoxine Hcl

View Indications, Usage & Precautions

Calamine Plus Pramoxine Hcl Product Label

The following document was submitted to the FDA by the labeler of this product Hy-vee, 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.


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: apply as needed to the affected area, not more than 3 or 4 times daily
  • cleanse the skin with soap and water
  • let dry before use
  • children under 2 years of age: consult a doctor

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



HyVee Health 

Calamine Plan Spray

Calamine 8% - Skin Protectant

Promoxine HCL 1% - External Analgesic

Drying action plus itch relief

Ideal for: poison ivy/ oak/ sumac

insect bites, minor skin irritations & cuts

SHAKE WELL BEFORE USE

NET WT 4.1 OZ (116 g)


* Please review the disclaimer below.