Label: REVIVE 1- menthol liquid

  • 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 October 21, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient:

    Menthol 2.50%

  • Purpose

    Topical Analgesic

  • Uses

    temporarily relieves minor pain associated with:

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

  • Warnings

    For external use only

    When using this product • use only as directed • do not bandage tightly or use with heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation or redness may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight

    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

    Flammable • keep away from fire or flame

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children over 12 years: • shake well before using every time • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 3 to 4 times daily

    MAKE SURE YOU SHAKE BOTTLE BEFORE EVERY TIME YOU APPLY IT

    children 12 years or younger: ask a doctor

  • Inactive Ingredients

    Emu Oil, Full Spectrum Hemp Oil (Cannabidiol), PPG-20 Methyl Glucose Ether, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate, Tincture of Iodine.

  • SPL UNCLASSIFIED SECTION

    FULL SPECTRUM CBD

    ROLL-ON

    contains 1200 mg of full spectrum hemp oil

    for temporary relief of minor aches and pains associated with ARTHRITIS SIMPLE ACHES AND PAINS SORE AND TIRED MUSCLES

    Please Call 877-577-2289

    MADE IN USA

  • Packaging

    Revive 1

  • INGREDIENTS AND APPEARANCE
    REVIVE 1 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69678-232
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EMU OIL (UNII: 344821WD61)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    OLETH-10 (UNII: JD797EF70J)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    IODINE (UNII: 9679TC07X4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69678-232-0388.7 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2021
    Labeler - EEZAWAY RELIEF INC (109456638)