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Coralite Extra Strength Cool and Hot

Medically reviewed on Jan 1, 2018

Dosage form: patch
Ingredients: MENTHOL 50mg in 1g
Labeler: United Exchange Corp.
NDC Code: 65923-145

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient                                                                        Purpose

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

Uses

Temporarily relieves minor pain associated with:

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

Warnings

For external use only

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

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
  • do not apply to wounds or damaged skin

Keep out of reach of children

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

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 age consult a doctor

Other information

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

Inactive ingredients

aloe vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate, Release Liner: polypropylene, non-woven material: polyester non-woven fabric

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

MADE IN KOREA

CORALITE EXTRA STRENGTH COOL AND HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-145
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALUMINUM HYDROXIDE 
CASTOR OIL 
GELATIN 
GLYCERIN 
ISOPROPYL MYRISTATE 
KAOLIN 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
SODIUM POLYACRYLATE (8000 MW) 
TARTARIC ACID 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:65923-145-055 PATCH in 1 BOX
11 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/30/2014
Labeler - United Exchange Corp. (840130579)

 
United Exchange Corp.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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