FDA Label for Duane Reade Hot And Cold Balm

View Indications, Usage & Precautions

Duane Reade Hot And Cold Balm Product Label

The following document was submitted to the FDA by the labeler of this product Duane Reade. 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 Purpose



Methyl Salicylate 29% .......................................................Topical Analgesic

Menthol 7.6% ....................................................................Topical Analgesic


Uses



temporarily relieves the minor pains associated with:

  • arthritis
  • cramps
  • bruises
  • sprains
  • backache

Warnings



For external use only


When Using This Product



  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged skin

Stop Use And Ask A Doctor If



  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions Adults And Children Over 12 Years:



  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily
  • children under 12 years: ask a doctor

Inactive Ingredients



purified water/aqua/eau, sd alcohol 40-b,

propylene glycol, isopropyl myristate,

glycerin, triethanolamine, carbomer


Allergy Alert:



If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

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