Label: C-PATCH GRANDE- menthol, camphor 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 January 13, 2018

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

  • Active ingredients

    Menthol (2.5%)

    Camphor (0.5%)

  • Purpose

    External analgesic

  • Uses

    temporarily relieves symptoms of:

    - pain

    - itching

    - inflammation

    - minor irritation

    - skin discomfort

    - swelling

  • Warnings

    For external use only

    When using this product

    Use only as directed.

    - Do not bandage tightly or use with heating pad

    - Avoid contact with eyes and mucus membranes

    - Do not appy wounds or broken skin

    - Do not apply to large areas of the body

    - In case of deep or puncture wounds, animal bites or serious burns, consult a doctor

    Stop use and ask a doctor if

    - condition worsen

    - irritation develops

    - symptoms persist for more than 7 days or recurs within 1 day of discontinuation

    - do not use for more than 7 days

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

    Keep out of reach of children. If swallowd, contact a Poison Control Center or get medical help immediately

  • Directions

    Adults and children over 12 years:

    - Clean affected skin

    - Remove film from patch

    - Carefully apply the patch to the affected region and press skin firmly

    - Patch can remain on the skin for up to 8 hours

    - May repeat as necessary up to a maximum of 3 times per day

    - For tick and bee stings, remove tick or stinger before applying patch

    Children 12 years and younger: ask a health professional

  • Inactive ingredients

    Charcoal, Gelatin, Aluminum Glycinate, Ethylenediaminetetraacetic acid disodium salt, Eucalyptus oil, Glycerin, Polyvinyl alcohol, Partially neutralized polyacrylate, Pured water, Salt, Sorbitol, Tartaric acid

  • Keep out of reach of childern

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

  • C-Patch Grande

    c patch grande

  • INGREDIENTS AND APPEARANCE
    C-PATCH GRANDE 
    menthol, camphor patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70236-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.7 g  in 28 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.14 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    SORBITOL (UNII: 506T60A25R)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    GELATIN (UNII: 2G86QN327L)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70236-101-026 in 1 POUCH01/13/2018
    1NDC:70236-101-0128 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/13/2018
    Labeler - NeoBiotech Global Corporation (080020820)
    Registrant - NeoBiotech Global Corporation (080020820)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoBiotech Global Corporation080020820manufacture(70236-101)