FDA Label for Pain Relieving Cooling

View Indications, Usage & Precautions

Pain Relieving Cooling 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


Active Ingredient



MENTHOL 3%


Purpose



EXTERNAL ANALGESIC


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings



For external use only.

Flammable: Keep away from fire or flame.


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

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 2 years and older: Apply liberally to painful area not more than 3-4 times daily.
  • Children under 2 years of age: Ask a doctor.
  • Wash hands carefully after using

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



Acrylates/C10-30 alkyl acrylate crosspolymer, polysorbate 60, SD alcohol 40B, tromethamine, water


Questions Or Comments?



1-800-243-9423


Principal Display Panel - 93 G Tube Label



97% NATURAL

ESTD
1868

J.R.
WATKINS
REMEDIES FOR BODY™

PAIN RELIEVING
COOLING
GEL

NATURAL
MENTHOL

TEMPORARY
RELIEF FOR
MUSCLES & JOINTS

NET WT. 3.3 OZ (93 g)


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