Label: BIO-RELIEF- menthol gel
BIO-RELIEF H- menthol gel

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

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Drug Label Information

Updated April 21, 2021

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  • PRINCIPAL DISPLAY PANEL

    Label

    Menthol 10%.

    Purpose: Topical Analgesic

    COOLING GEL W 10% MENTHOL IN ARNICA TINCTURE

    FOR ARTHRITIS, SPRAINS, SORE MUSCLES, BRUISES, & BACK PAIN

    FAST ACTING COOLING PAIN RELIEF

    FOR EXTERNAL USE ONLY

    FLAMMABLE, KEEP AWAY FROM 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.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    BIO-RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    THYMOL (UNII: 3J50XA376E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    BOSWELLIA SACRA BARK (UNII: 1UK28DX728)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Product Characteristics
    Colorwhite (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81376-003-0189 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2021
    BIO-RELIEF H 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    THYMOL (UNII: 3J50XA376E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Product Characteristics
    Colorwhite (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81376-004-0189 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2021
    Labeler - SSG Ventures Inc (047626115)
    Establishment
    NameAddressID/FEIBusiness Operations
    SSG Ventures Inc047626115manufacture(81376-003, 81376-004)
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