Label: AK47 MENTHOL WARMING- menthol cream

  • NDC Code(s): 76348-575-04, 76348-575-10
  • Packager: RENU LABORATORIES, INC.
  • 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 August 13, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol 5 percent

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses: for temporary relief of minor aches and pains associated with

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
  • WHEN USING

    When using this product: Do not bandage tightly • avoid contact with eyes • do not apply to wounds or damaged skin • do not use heating pads or other heating devices.

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with eyes and sensitive areas

  • STOP USE

    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, seek medical help or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and older

    • apply liberally to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary
  • INACTIVE INGREDIENT

    Butyrospermum Parkii (Shea) Butter, Cannabis Sativa Hemp Seed Oil and Hemp Derived Cannabidiol (CBD) Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Capsicum Frutescens Fruit Extract, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, C13-14 Isoparaffin, Deionized Water, Emulsifying Wax, Fragrance, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel), Laureth-7, Magnesium Chloride, Mangifera Indica (Mango) Seed Butter, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Olus Oil (Vegetable), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Stearic Acid

  • QUESTIONS

    Questions

    info@ak47painrelief.com

  • PRINCIPAL DISPLAY PANEL

    BOX OF 10PACKETTE

  • INGREDIENTS AND APPEARANCE
    AK47 MENTHOL WARMING 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.2 g  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CORN OIL (UNII: 8470G57WFM)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TABASCO PEPPER (UNII: J1M3NA843L)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    PINENE (UNII: 996299PUKB)  
    TERPINEOL (UNII: R53Q4ZWC99)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRCENE (UNII: 3M39CZS25B)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-575-1010 in 1 BOX08/13/2020
    1NDC:76348-575-044 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/13/2020
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-575)
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