Label: CORALITE ULTRA STRENGTH PAIN RELIEF- camphor menthol ointment

  • 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 March 31, 2022

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  • 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 not finalpart34810/15/2014
    Labeler - United Exchange Corp. (840130579)
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