Label: AK47 MENTHOL COOLING- menthol cooling cream

  • 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 July 23, 2020

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  • ACTIVE INGREDIENT

    Menthol

    5%

  • 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

  • PURPOSE

    Topical Analgesic

  • QUESTIONS

    Questions or Comments

    info@ak47painrelief.com

  • 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

    For external use only

  • INDICATIONS & USAGE

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

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
  • Directions

    adults and children 12 years of age and older

    • apply generously to affected area
    • massage into painful area until thoroughy 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), 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.

  • PRINCIPAL DISPLAY PANEL

    COOLING CREAM LABEL

    COOLING CREAM LABEL

    COOLING CREAM BOX

    COOLING CREAM BOX

  • INGREDIENTS AND APPEARANCE
    AK47 MENTHOL COOLING 
    menthol cooling cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-522
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.6 g  in 112 g
    Inactive Ingredients
    Ingredient NameStrength
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    PINENE (UNII: 996299PUKB)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    CORN OIL (UNII: 8470G57WFM)  
    MYRCENE (UNII: 3M39CZS25B)  
    TERPINEOL (UNII: R53Q4ZWC99)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-522-011 in 1 BOX07/20/2020
    1NDC:76348-522-04112 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/20/2020
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-522)
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