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

  • NDC Code(s): 65923-148-02
  • Packager: United Exchange Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2024

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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 (800000 mw), polyisobutylene (85000 mw), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

  • QUESTIONS

    Call 1-800-814-8028 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:65923-148
    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
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    LANOLIN (UNII: 7EV65EAW6H)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
    POLYISOBUTYLENE (85000 MW) (UNII: 7X53O5S2ZY)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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 DrugM01710/23/2018
    Labeler - United Exchange Corporation (840130579)
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