FDA Label for Sound Body Extra Strength Cold And Hot Medicated

View Indications, Usage & Precautions

Sound Body Extra Strength Cold And Hot Medicated Product Label

The following document was submitted to the FDA by the labeler of this product United Exchange Corp.. 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.

Otc - Active Ingredient



Active ingredeint                                                                           Purpose

Menthol 5%.............................................................................. Topical analgesic


Otc - Purpose



Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • bursitis
  • tendonitis
  • sprains
  • bruises
  • cramps

Warnings



Warnings

For external use only


Otc - When Using



When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • redness is present
  • skin irritation develops

Otc - Ask Doctor



Stop use and ask a doctor if

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

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. In case of accidental ingestion, get medical help or contact a Poison Control Center right away


Indications & Usage



Directions

adults and children 12 years of age and older

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children 12 years of younger: ask a doctor

Storage And Handling



Other information

  • store at room temperature, not to exceed 86°F (30°C)

Inactive Ingredient



Inactive ingredients

aluminum hydroxide, camphor, eucalyptus oil, glycerine, methylparaben, polyacrylic acid, propaneidol, propylparaben, purified water


Dosage & Administration



DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703

MADE IN CHINA


Package Label.Principal Display Panel




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