CORALITE PAIN RELIEF- menthol capsaicin patch 
United Exchange Corp.

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.

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Active Ingredients                                              Purpose

Menthol 30 mg................................................ Topical analgesic

Capsaicin 8.3 mg............................................. Topical analgesic

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • 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 doctor if:

  • condition worsens
  • symptoms persist 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 Control Center right away.

Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 year of age: do not use, consult a doctor
  • For easy applications: partially peel back protectice film and apply exposed patch to site of pain.
  • Carefully remove remaining film while pressing patch to skin for secure adhesion.

Inactive ingredients

aloe 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, purifed water, PVP, sodium

polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

DISTRIBUTED BY:

UNITED EXCHNAGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703 USA

image description

CORALITE PAIN RELIEF 
menthol capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN8.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
ALMASILATE (UNII: OZQ8O62H53)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-152-022 in 1 POUCH07/13/2017
11 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/12/201307/15/2020
Labeler - United Exchange Corp. (840130579)

Revised: 12/2021
 
United Exchange Corp.