Label: REVIVE 2- 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 May 17, 2022

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

  • Drug Facts

  • Active Ingredient:

    Menthol 2.75%

  • 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

    For Adults and Children over 12     SHAKE WELL BEFORE EACH USE
    • apply generously to affected area • massage into painful area until completely absorbed • You may apply 4 to 6 times a day or as needed
    • Children under 12 years - ask your doctor.

  • Inactive Ingredients

    Carbomer, Arnica (Helianthus Annus, Sunflower Seed Oil, Arnica Montana Flower Extract), PPG-20 Methyl Glucose Ether, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate, Tincture of Iodine.

  • SPL UNCLASSIFIED SECTION

    Sport Pain Relief Roll-on

    ARNICA + COOLING MENTHOL

    R2

    Temporary relief of minor pain associated with ARTHRITIS, MUSCULAR ACHES, STRAINS, SORENESS AND BACKACHE

    MADE IN USA

    Manufactured For:
    Revive 1, LLC
    Incline Village, NV 89451
    www.revive1.net   877-577-2289

  • Packaging

    Label

  • INGREDIENTS AND APPEARANCE
    REVIVE 2 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69678-424
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    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:69678-424-0488 mL in 1 BOTTLE; Type 0: Not a Combination Product05/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/17/2022
    Labeler - EEZAWAY RELIEF INC (109456638)