Coralite Muscle & Joint Pain Relief patch 2ct (90155, 2018)

Coralite Muscle & Joint Pain Relief patch 2ct (90155, 2018)

Drug Labeling and Warnings

Drug Details

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CORALITE MUSCLE AND JOINT PAIN RELIEF- camphor, menthol, and mehtyl salicylate patch 
United Exchange Corporation

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 Muscle & Joint Pain Relief patch 2ct (90155, 2018)

Active Ingredients Purposes

Camphor 1.2%...................Topical analgesic

Menthol 5.7%.....................Topical analgesic

Methyl salicylate 6.3%.......Topical analgesic

Uses

  • temporarily relieves the minor aches and pains of muscles and joints associated with:
  • sprains
  • simple backache
  • arthritis
  • strains
  • bruises

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area.

When using this product

  • do not use otherwise than as directed
  • avoid contact with eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop use and ask a doctor if

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

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 (1-800-222-1222) right away.

Directions

  • open pouch and remove patch
  • carefully peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older:
  • clean and dry affected area
  • apply to affected area no more than3 times daily
  • do not wear patch for more than 8 hours
  • children under 12 years of age: consult a doctor

  • store at room temperature 20-25°C (68-77ºF)

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

Call 1-800-814-8028 Monday-Friday 9AM-5PM (PST)

Distributed By:

UNITED EXCHANGE CORP.

5836 Corporate Ave.

Cypress, CA. 90630 USA

1-800-814-8028

Made in China

90155

CORALITE MUSCLE AND JOINT PAIN RELIEF 
camphor, menthol, and mehtyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65923-148
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)12 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL57 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE63 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
LANOLIN (UNII: 7EV65EAW6H)  
PETROLATUM (UNII: 4T6H12BN9U)  
ROSIN (UNII: 88S87KL877)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65923-148-021 in 1 POUCH10/23/2018
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 finalpart34810/23/2018
Labeler - United Exchange Corporation (840130579)

Revised: 12/2018
 
United Exchange Corporation


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