FDA Label for Pain Relieving Warming Balm

View Indications, Usage & Precautions

Pain Relieving Warming Balm Product Label

The following document was submitted to the FDA by the labeler of this product J.r. Watkins, 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.

Other



Drug Facts


Otc - Purpose



Active IngredientsPurpose
MENTHOL 1.25%EXTERNAL ANALGESIC
METHYL SALICYLATE 10.0% EXTERNAL ANALGESIC

Uses



temporarily relieves minor aches and pains of muscles and joints associated with

  • simple backache
  • strains
  • bruises
  • sprains
  • arthritis

Warnings



For external use only.


Allergy Alert



If prone to allergic reaction form aspiring or salicylates, consult a doctor before use.


Do Not Use



  • on wounds or damaged skin
  • with a heading pad

When Using This Product



  • avoid contact with eyes, nostrils and mouth
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash or irritation occurs
  • taking anticoagulant medications

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding ask a health professional before use


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Use only as directed
  • Adults and children 3 years and older: Apply to affected area not more than 3-4 times daily.
  • Children under 3 years of age: Ask a doctor.

Other Information



  • do not use if tamper evident seal is not intact
  • store away from children
  • store in dry, well-ventilated conditions at room temperature (59-77°F)

Inactive Ingredients



Capsicum oleoresin, glyceryl stearate SE, phenoxyethanol, stearic acid, stearyl alcohol, tropolone, water


Questions Or Comments?



1-800-243-9423


Principal Display Panel - 93 G Tube Label



99% NATURAL

ESTD J.R. 1868
WATKINS
REMEDIES FOR BODY™

PAIN RELIEVING
WARMING
BALM

NATURAL
MENTHOL

METHYL
SALICYLATE

FAST–ACTING
LONG–LASTING
PAIN RELIEF

NET WT. 3.3 OZ (93 g)


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