Label: CORALITE MUSCLE AND JOINT PAIN RELIEF- camphor, menthol, and mehtyl salicylate patch

  • NDC Code(s): 65923-163-02
  • Packager: United Exchange Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 13, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients Purposes

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

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

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

  • PURPOSE

    Uses

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

    For external use only

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

  • DO NOT 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 DOCTOR

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

  • WHEN USING

    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

    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
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older:
    • clean and dry affected area
    • remove patch from film
    • apply to affected area no more than 3 to 4 times daily
    • do not wear patch for more than 4 hours
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    • store at room temperature 20-25°C (68-77ºF)
    • avoid storing product in direct sunlight
    • protect product from excessive moisture
  • INACTIVE INGREDIENT

    Inactive ingredients

    aluminum silicate, butylated hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin, polyisobutylene (80000 mw), polyisobutylene (85000 mw), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

  • QUESTIONS

    Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

  • DOSAGE & ADMINISTRATION

    Distributed By:

    UNITED EXCHANGE CORP.

    Cypress, CA. 90630 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    90155

  • INGREDIENTS AND APPEARANCE
    CORALITE MUSCLE AND JOINT PAIN RELIEF 
    camphor, menthol, and mehtyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-163
    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
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LANOLIN (UNII: 7EV65EAW6H)  
    POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-163-021 in 1 POUCH01/13/2023
    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 finalpart34801/13/2023
    Labeler - United Exchange Corporation (840130579)
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