Label: CORALITE PAIN RELIEF STICK- menthol, and methyl salicylate stick

  • 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 February 10, 2016

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  • ACTIVE INGREDIENT

    Active ingredients                                                           Purpose

    Methol 4%.......................................................Topical analgesic

    Methyl salicylate 1%.........................................Topical analgesic

  • PURPOSE

    Uses

    For temporary relief of minor muscle and joint discomfort associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

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

    Allergy Alert: Do not use if allergic to salicylates (including aspirin) without consulting a physician.

  • WHEN USING

    When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes and mucous membranes, do not apply to wounds or damaged skin.

  • STOP USE

    Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, redness is present or irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    Adults and Children 10 Years of Age and Older

    • Apply generously to affected area
    • Massage into area until thoroughly absorbed into skin
    • Repeat as necessary, but no more than 4 times daily

    Childreun Under 10 Years of Age Consult a doctor

  • STORAGE AND HANDLING

    Other information

    • Store at 20° to 25°C (68° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients ethyl alcohol, hydrogenated castor oil, PEG-150 distearate, propylene glycol, sodium stearate, water

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    www.ueccorp.com

    Toll Free: 1 800 814 8028

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CORALITE PAIN RELIEF STICK 
    menthol, and methyl salicylate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-120-0157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2016
    Labeler - United Exchange Corp. (840130579)
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