Label: TVIA TOPICAL GEL- menthol, camphor gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 5, 2019

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS
    Menthol 3.5%
    Camphor 0.2%

  • PURPOSE

    PURPOSE
    Menthol ............................Topical Analgesic
    Camphor ..........................Topical Analgesic

  • INDICATIONS & USAGE

    USES: For temporary relief from minor aches and
    pains of sore muscles and joints associated with:
    arthritis pain • backache • strains • sprains

  • WARNINGS AND PRECAUTIONS

  • WARNINGS

    WARNINGS: For external use only.

  • OTHER SAFETY INFORMATION

    Flammable: Keep away from excessive heat or open flame.

  • ASK DOCTOR

    Ask a doctor before use if you have: Sensitive skin

  • WHEN USING

    When using this product: Avoid contact with the eyes
    and/or mucous membranes • Do not use with other
    sprays, ointments, creams or liniments • Do not apply
    to irritated skin, & discontinue use if excessive skin
    irritation develops • Do not bandage • Do not use
    with heating pads or device.

  • STOP USE

    Stop use and contact your physician if: conditions
    worsen, or if symptoms persist for more than seven (7)
    days, or clear up and reoccur.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding: Ask a health
    professional before use. Children under 2 years of age:
    Consult physician

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN: If swallowed,
    get medical help or contact a poison control center
    immediately

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Use only as directed. Rub a thin film
    over the affected areas not more than four (4) times
    daily. Rinse hands after use with cool water.

  • OTHER SAFETY INFORMATION

    OTHER INFORMATION: Store in a cool, dry place
    with lid closed tightly.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Ethyl Alcohol Denatured,
    Deionized Water, Glycerin, Propylene Glycol, Cannabis
    Sativa Seed Oil (Hemp Seed Oil), Cannabidiol (CBD), Arnica
    Montana Flower Extract (Arnica Oil), Mentha Piperita
    (Peppermint) Oil, Carbomer, Triethanolamine, Mentha Viridis
    (Spearmint) Leaf Oil, Camellia Sinensis Leaf Extract, Aloe
    Barbadensis Leaf Extract, Hamamelis Virginiana (Witch
    Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil,

  • Principal Display Package

    NDC# 72380-728-10

    VIVERA®
    PHARMACEUTICALS

    TVIA GEL®
    T O P I C A L   G E L

    PAIN RELIEF

    BOX CONTAINS:
    3 FL OZ (88.7mL)
    TOPICAL GEL

    6 16728 00071 2

    TVIA GEL®
    T O P I C A L   G E L

    SUGGESTED USE: Apply a
    small amount topically to
    affected area and rub in. Use
    every 4 to 6 hours. Safe for
    use on adults over 21 years
    of age. Wash hands with cool
    water after each use.

    WARNINGS: Do not exceed
    suggested use. This product
    is not intended for pregnant
    or lactating mothers. All
    individuals should consult with
    a health practitioner prior
    to use. If you experience any
    adverse reactions after use,
    please discontinue and consult
    your doctor. Keep out of reach
    of children. This product has
    not been evaluated by the
    Food and Drug Administration.

    VIVERA®
    PHARMACEUTICALS

    *These statements have not been
    evaluated by the Food and Drug
    Administration. This product is not
    intended to diagnose, treat, cure or
    prevent any disease.

    VIV-71000-GBX          REV20190115

    VIVERA®
    PHARMACEUTICALS

    Manufacrured For:
    Vivera Pharmaceuticals, Inc.
    11100 Greenstone Ave
    Santa Fe Springs, CA 90670

    MADE IN USA

    Retail Box

    TVIA Box 3oz

    Tube

    TVIA tube

    Insert

    TVIA insert

                                                    TVIA Topical Gel by Vivera Pharmaceuticals, Inc.

    res

  • INGREDIENTS AND APPEARANCE
    TVIA TOPICAL  GEL
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72380-728
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PAPRIKA (UNII: X72Z47861V)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72380-728-101 in 1 BOX12/01/2018
    188.7 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2018
    Labeler - Vivera Pharmaceuticals, Inc. (081244342)