Label: CMC PAIN RELIEVING- .alpha.,.alpha.-dibromo-d-camphor, menthol, unspecified form, and capsaicin patch

  • 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 May 26, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Camphor 3%External Analgesic
    Menthol 1.25%External Analgesic
    Capsaicin 0.025%External Analgesic
  • Uses

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

    • Simple backaches
    • Arthritis
    • Strains
    • Sprains
  • Warnings

    FOR EXTERNAL USE ONLY. Avoid contact with eyes.

    Do not use

    • On wounds or damaged skin
    • With a bandage or heating pad
    • On sensitive skin
    • if allergic to any ingredient in this product

    Stop use and ask a doctor if

    • Condition worsens
    • symptoms persist for more than 7 days
    • clear up and occur again within a few days
    • redness is present

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

    KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
    • Children under 12 years of age consult a doctor
    • clean and dry affected area
    • remove patch from film
    • apply sticky side of patch to affected area
    • use one patch at a time
    • leave patch on affected area for up to 8 hours at a time
  • Other Information

    • Store at room temperature 59-86°F (15-30°C)
    • Do not store in direct sunlight or expose to excessive heat

    TAMPER EVIDENT: Do not use if packet containing the patch is torn or broken

  • Inactive Ingredients

    Adhesive plaster

  • Questions

    Call +91 9212228401

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    UNEXO LIFE SCIENCES PVT. LTD.
    B-16. Sector 4, Bawana Industrial Area,
    Delhi – 110039 (INDIA)

  • PRINCIPAL DISPLAY PANEL - 6 Pouch Box

    NDC: 71391-125-06

    UNEXO's
    PAIN RELIEVING
    HOT PATCH

    External Analgesic

    Penetrating pain relief for:

    • Back Aches
    • Muscles
    • Arthritis

    6
    Adhesive Plaster Patches
    4.72 in x 7.07 in (12 cm x 18 cm)

    PRINCIPAL DISPLAY PANEL - 6 Pouch Box
  • INGREDIENTS AND APPEARANCE
    CMC PAIN RELIEVING 
    .alpha.,.alpha.-dibromo-d-camphor, menthol, unspecified form, and capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR (UNII: F89Z8SAG3O) (.ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR - UNII:F89Z8SAG3O) .ALPHA.,.ALPHA.-DIBROMO-D-CAMPHOR129.6 mg
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM54 mg
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1.08 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-125-011 in 1 POUCH; Type 0: Not a Combination Product06/01/2020
    2NDC:71391-125-066 in 1 BOX06/01/2020
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2020
    Labeler - Unexo Life Sciences, Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences, Private Limited872260479MANUFACTURE(71391-125)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!