Label: THE BLACK PATCH- menthol 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 December 22, 2017

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

  • Drug Facts

  • Active ingredient (in each patch)

    Menthol 4%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • Warnings

    For external use only

    When using this product

    • use only as directed
    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

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

  • 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.

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Consult a doctor.
  • Inactive ingredients

    activated charcoal, disodium EDTA, ethanol, gelatin, glycerin, polysorbate 80, polyvinyl alcohol, salt, sodium polyacrylate, tartaric acid, water

  • Questions or Comments?

    1-800-254-5041

  • SPL UNCLASSIFIED SECTION

    HYDROGEL PAIN RELIEF PATCH with MENTHOL

    • Soothing relief for painful joints and muscles
    • Lasts up to 8 hours
    • Just peel and stick
    • Contains activated charcoal for smoother skin!

    Direction1

    Care Instructions

    • The hydrogel must contact the skin for best results. Clean the skin of oil, dirt, lotions, etc. and dry completely.
    • It is sometimes helpful to use medical tape around the edges or a tension bandage to hold the patch securely in place.
    • The Black Patch is designed to apply easily and remove residue-free. However, due to heat, excessive moisture, or other factors, some hydrogel residue may transfer.
    • If residue transfers onto the skin or clothing, simply wash off with warm water or in the laundry.
    • The Black Patch is proudly made in America with natural, food grade ingredients. However, it's not edible so keep it out of reach of small children.

    Manufactured by

    Carbon Innovation

    600 Business Park Dr

    Lincoln, CA 95648

  • Packaging

    TBlkPtch

  • INGREDIENTS AND APPEARANCE
    THE BLACK PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71948-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALCOHOL (UNII: 3K9958V90M)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL/POLYVINYL ACETATE COPOLYMER (8:1; 50000 MW) (UNII: 8K8B5SD7ZR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorblack, white (black and white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71948-101-055 in 1 PACKAGE12/30/2017
    10.348 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:71948-101-1010 in 1 BOX12/30/2017
    25 in 1 PACKAGE
    20.348 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 finalpart34812/30/2017
    Labeler - Carbon Innovation, Inc. (080987228)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carbon Innovation, Inc.080987228manufacture(71948-101)