FDA Label for Therapeutic Icy Cold Cooling Pain Relief

View Indications, Usage & Precautions

Therapeutic Icy Cold Cooling Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Apex-carex Heathcare Products. 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



NATURAL MENTHOL 6%


Purpose



COOLING PAIN RELIEF


Uses



TEMPORARY RELIEF OF

  • ARTHRITIS
  • BACKACHE
  • STRAINS
  • SPRAINS

Warnings



FOR EXTERNAL USE ONLY.

DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGES.

DO NOT USE IF PREGNANT OR BREASTFEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.

IF ACCIDENTALLY INGESTED, SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.


Directions



  • SHAKE GENTLY
  • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER, SPRAY ONTO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.
  • RUB IN THOROUGHLY UNTIL GEL IS ABSORBED.

Inactive Ingredients



WATER, SD ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT (YERBA MATE), HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT (CAT'S CLAW), BOSWELIA SERRATA EXTRACT, CAMPHOR FOR SCENT


Package Label.Principal Display Panel




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