Label: CORALITE PAIN RELIEF- camphor (synthetic), levomenthol and methyl salicylate patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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

  • Coralite Pain Relief Patch 20 Ct

    Active ingredients                                     Purpose

    DL-Camphor 1.2%.................................. Topical Analgesic

    L-Menthol 5.7%...................................... Topical Analgesic

    Methyl Salicylate 6.3%............................ Topical Analgesic

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  • PURPOSE

    Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

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

    Warnings

    For external use only

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  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • if you are allergic to aspirin or salicylates
    • with a heating pad
    • with, or at the same time as, other external analgesic products

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  • ASK DOCTOR

    Ask a doctor before use if you allergic to any ingredients of this product

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  • WHEN USING

    When using this product

    • do not use other than directed
    • avoid contact with the eyes, mucous membranes or rashes
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  • ASK DOCTOR

    Stop use and ask a doctor if

    • rash, itching or excessive skin irritation develops
    • conditions worsen symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
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  • KEEP OUT OF REACH OF CHILDREN

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

    Caution: This product contains natural rubber latex which may cause allergic reactions

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  • STORAGE AND HANDLING

    Other information

    • avoid storing product in direct sunlight
    • protect from excessive moisture
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  • INACTIVE INGREDIENT

    Inactive ingredients BHT, calcium carbonate, C4-6 olefin/styrene copolymer, glyceryl abiertate, isopropyl myristate, polybutene, polyisobutylene, propylene carbonaterubber latex, sorbitan stearate, ys resin, zinc oxide

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  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    UNITED EXCHANGE CORP.

    17211 VALLEY VIEW AVE.

    CERRITOS, CA 90703 USA

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  • INGREDIENTS AND APPEARANCE
    CORALITE PAIN RELIEF 
    dl-camphor, l-menthol, methylsalicylate patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65923-156
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 1.2 g  in 100 g
    LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 5.7 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 6.3 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE  
    CALCIUM CARBONATE  
    STYRENE  
    GLYCERYL ABIETATE  
    ISOPROPYL MYRISTATE  
    POLYISOBUTYLENE (1000 MW)  
    POLYBUTENE (1400 MW)  
    PROPYLENE CARBONATE  
    ZINC OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-156-20 20 in 1 PACKAGE
    1 1 g in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/26/2014
    Labeler - United Exchange Corp. (840130579)
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