Label: OP 6 MENTHOL COOLING ROLL ON- menthol liquid

  • NDC Code(s): 76348-670-01, 76348-670-03
  • 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 2, 2021

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  • ACTIVE INGREDIENT

    Active ingredient

    Menthol 5 percent

  • 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
  • WARNINGS

    Warnings

    For external use only

  • 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.

  • DOSAGE & ADMINISTRATION

    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, consulta a doctor.
  • INACTIVE INGREDIENT

    Arnica Montana (Arnica) Flower Extract, Cannabis Sativa (Hemp) Seed Oil and Hemp Derived Cannabidiol Extract with proprietary terpene blend (Limonene, Myrcene, Caryophyllene, Linalool, Pinene, Terpineol), Deionized Water, Fragrance, Hamamelis Virginiana (Witch Hazel), Hydroxyethyl Cellulose, Isopropyl Alcohol, Magnesium Chloride, Mentha piperita (Peppermint) Leaf Oil, Polysorbate 80, Potassium Sorbate, Sodium Benzoate.

  • QUESTIONS

    Questions? Comments?

    www.HempforLifeWellness.com

  • PRINCIPAL DISPLAY PANEL

    PRODUCT LABEL AND PRODUCT BOX

    Label 2 coolingLabel 1_cooling roll-on

  • INGREDIENTS AND APPEARANCE
    OP 6 MENTHOL COOLING ROLL ON 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-670
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.2 g  in 84 g
    Inactive Ingredients
    Ingredient NameStrength
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    PINENE (UNII: 996299PUKB)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    MYRCENE (UNII: 3M39CZS25B)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-670-011 in 1 BOX08/02/2021
    1NDC:76348-670-0384 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/02/2021
    Labeler - RENU LABORATORIES, INC. (945739449)
    Registrant - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-670)
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