Label: BIO-RELIEF- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 11, 2020

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

View All Sections
  • PRINCIPAL DISPLAY PANEL

    Label

    Menthol 10%

    Topical Analgesic

    For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains• bruises • sprains

    For external use only. Flammable, keep away from fire/flame.

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

    Adults & children 2 yrs of age and older: Apply to affected area not more than 4 times daily in one direction, not circular. Children under 2 years of age, consult a physician. Massage not necessary. Shake well before use.

    Aloe Vera Oil, Arnica Flower Tincture, Boswellia Powder, Camphor, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Propylene Glycol, Tea Tree Oil, Thymol, Vitamin E.

    Store in a cool and dry place with lid closed tightly.

    Questions or Comments? E-mail: info@scisolglobal.com Manufactured and Distributed by: Scientific Solutions Global LLC, Carle Place, NY, USA

  • INGREDIENTS AND APPEARANCE
    BIO-RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71718-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8.9 g  in 89 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    THYMOL (UNII: 3J50XA376E)  
    Product Characteristics
    Colorwhite (Opaque gel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71718-200-0189 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2020
    Labeler - Scientific Solutions Global LLC (097291290)
    Registrant - Scientific Solutions Global LLC (097291290)
    Establishment
    NameAddressID/FEIBusiness Operations
    Scientific Solutions Global LLC097291290manufacture(71718-200)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!