Coralite Pain Patch 40 ct.

Coralite Pain Patch 40 ct.

Drug Labeling and Warnings

Drug Details

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CORALITE PAIN RELIEF- camphor, menthol, methyl salicylate 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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Coralite Pain Patch 40 ct.

Active ingredients Purpose

Camphor 1.2%........................................Topical Analgesic

Menthol 5.7%..........................................Topical Analgesic

Methyl Salicylate 6.3%............................Topical Analgesic

Uses

For temporary relief of minor aches & pains of muscles & joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

When using this product

  • do not use other than directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

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

Keep out of reach of children. If swallowed, get medical help or conduct a Poision Control Center right away

Directions

adults and children 12 years of age and over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8 hours' application

children under 12 years of age:

  • consult a doctor

Other information

  • avoid storing product in direct sunlight
  • protect from excessive moisture

Inactive ingredients

lanolin, natural rubber, petrolatum, polyisobutylene, rosin, zinc oxide

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Suite 200

Cypress, CA 90630 USA

Made in China

90156

CORALITE PAIN RELIEF 
camphor, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65923-564
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.7 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
PETROLATUM (UNII: 4T6H12BN9U)  
ROSIN (UNII: 88S87KL877)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65923-564-2020 in 1 PACKAGE04/12/2018
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 finalpart34804/12/2016
Labeler - United Exchange Corp. (840130579)

Revised: 12/2018
 
United Exchange Corp.


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