Label: BLACK ICE MEDICATED PATCHES- menthol patch

  • Category: HUMAN OTC DRUG LABEL

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 July 16, 2018

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  • Drug Facts

  • Active ingredient (in each patch)

    Menthol 5%

  • 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 • do not apply to wounds or damaged skin • avoid contact with eyes • 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.

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

  • 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.
    • Clean skin of oil, dirt, lotions, etc. and dry completely before use.
    • If necessary, use medical tape, tension bandage or sleeve to secure in place.
  • Inactive ingredients

    activated charcoal, alcohol, borneol, dihydroxyaluminum aminoacetic acid, disodium EDTA, DMDM ethyl urea, glycerin, polyvinyl pyrrolidone povidone K30, sodium polyacrylate, water

  • SPL UNCLASSIFIED SECTION

    HYDROGEL PATCH with ACTIVATED CHARCOAL

    * helps relieve minor aches and pains of muscles and joints

    * pain-relieving menthol on a breathable adhesive patch

    * hydrogel infused with charcoal for smoother skin

    * resealable pouch

    * lasts up to 8 hours

    VEGAN

    No animal products or animal testing

    For more info about charcoal and other free health resources, go to lifeandhealth.org

    Distributed by Carbon Biotech LLC

    110 Flocchini Circle, Ste 400

    Lincoln, CA 95648

    Made in China

  • Packaging

    BlkIce1-2

  • INGREDIENTS AND APPEARANCE
    BLACK ICE MEDICATED PATCHES 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72411-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.156 g
    Inactive Ingredients
    Ingredient NameStrength
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    ALCOHOL (UNII: 3K9958V90M)  
    BORNEOL (UNII: M89NIB437X)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblackScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72411-102-011 in 1 PACKAGE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2018
    Labeler - Carbon Biotech Llc (081166374)
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