Label: CORALITE ULTRA STRENGTH PAIN RELIEF- camphor menthol ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                                       Purpose

    Camphor 11%........................................................ Topical analgesic

    Menthol 11%.......................................................... Topical analgesic

  • PURPOSE

    Uses

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

  • WARNINGS

    Warnings

    For external use only

    Allergy alert: This product may cause allergic reaction in some individuals. Test on small area before use.

  • DO NOT USE

    Do not use

    • on wounds, damaged or irritated 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
  • WHEN USING

    When using this product

    • do not use otherwise than as directed
    • avoid contact with the 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
    • condition 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 healthcare 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 immediately

  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older:
    • rub well on the affected area. Repeat 3 to 4 times daily.
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    clove oil, paraffin, peppermint oil, petrolatum

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    Cypress, CA 90630 USA

    1-888-645-8204

    Made in China

  • PRINCIPAL DISPLAY PANEL

    532.1

  • INGREDIENTS AND APPEARANCE
    CORALITE ULTRA STRENGTH PAIN RELIEF 
    camphor menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-532
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)110 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL110 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CLOVE OIL (UNII: 578389D6D0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-532-181 in 1 CARTON12/13/2017
    118 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/15/2014
    Labeler - United Exchange Corp. (840130579)