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Coralite Cold and Hot by United Exchange Corp.

Dosage form: patch
Ingredients: MENTHOL 5mg in 1g
Labeler: United Exchange Corp.
NDC Code: 65923-151

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 aches and pains of muscles and joint due to:

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

Warnings

For external use only´╗┐

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

Stop use and ask a doctof if:

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Contro 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 hours a day
  • children under 12 years of age: consult a doctor

´╗┐Other information

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

Inactive Ingredients

alove vera gel, BHT, castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydroxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminosilicate, methylparaben, PEG monostearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate 

DISTRIBUTED BY:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

CORALITE COLD AND HOT 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-151
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BUTYLATED HYDROXYTOLUENE 
CASTOR OIL 
GLYCERIN 
EDETATE DISODIUM 
ALUMINUM ACETATE 
GELATIN 
ISOPROPYL MYRISTATE 
KAOLIN 
ALMASILATE 
METHYLPARABEN 
POLYSORBATE 80 
POLYVINYL ALCOHOL, UNSPECIFIED 
WATER 
SODIUM POLYACRYLATE (8000 MW) 
TARTARIC ACID 
TITANIUM DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:65923-151-011 PATCH in 1 POUCH
15 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/12/2013
Labeler - United Exchange Corp. (840130579)

Revised: 07/2017
 
United Exchange Corp.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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