Label: AK47 MENTHOL COOLING CREAM PACKET- menthol cream

  • NDC Code(s): 76348-576-04, 76348-576-10
  • 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 25, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 5 %

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    for temporary relief of minor aches and pains of muscles and joints associated with

    • bruises
    • sprains
    • arthritis
    • strains
  • 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 with heating pads or other heating devices
  • 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, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older, apply to affected area no more than 10 times a day as needed for pain.
    • children under 12 years of age, do not use, consult a doctor.
  • INACTIVE INGREDIENT

    Butyrospermum Parkii (Shea Butter), Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol (CBD) with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), 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

    info@ak47painrelief.com

  • WARNINGS

    For external use only.

  • PRINCIPAL DISPLAY PANEL

    Cooling Pack

    AND PRODUCT BOX

    BOX OF 10

    BOX OF 10 COOLING PACKETS

  • INGREDIENTS AND APPEARANCE
    AK47 MENTHOL COOLING CREAM PACKET 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-576
    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
    MYRCENE (UNII: 3M39CZS25B)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    PINENE (UNII: 996299PUKB)  
    TERPINEOL (UNII: R53Q4ZWC99)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CORN OIL (UNII: 8470G57WFM)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-576-1010 in 1 BOX08/13/2020
    1NDC:76348-576-044 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(76348-576)
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