Label: OPITOX 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 of minor aches and pains
    of sore muscles and joints associated with:
    • arthritis
    • backache
    • strains
    • sprains

  • 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; Not for ophthalmic
    use; Do not apply to wounds or damaged skin; Do not
    use with other sprays, ointments, creams or liniments;
    Do not apply to irritated skin or if excessive irritation
    develops; Do not bandage; Do not use with heating
    pads or device.

  • STOP USE

    Stop use and contact your physician if:
    Condition worsens, irritation develops, or if symptoms
    persist for more than seven (7) days, or clear up
    and recur.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: If accidentally
    ingested, get medical help or contact a Poison Control
    Center immediately.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding: Ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions:
    Adults and Children 12 years of age and older:
    Rub a thin film over affected area(s) not more than
    four (4) times daily. Rinse hands with cool water after
    use. Use only as directed.

    Children under 12 years of age: Consult physician

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive Ingredients: SD Alcohol 40-B, Water,
    Carbomer, Glycerin, Cannabis Sativa (Hemp) Seed Oil,
    Cannabidiol (CBD), Aloe Barbadensis Leaf Juice, Arnica
    Montana Flower Extract, Mentha Piperita (Peppermint)
    Oil, Mentha Viridis (Spearmint) Leaf Oil, Propylene
    Glycol, Hamamelis Virginiana (Witch Hazel) Extract,
    Melaleuca Alternifolia (Tea Tree) Leaf Oil, Capsicum
    Annuum Fruit Extract, Camellia Sinensis (Green
    Tea) Leaf Extract, Phenoxyethanol, Caprylyl Glycol,
    Ethylhexylglycerin, Hexylene Glycol, Triethanolamine

  • QUESTIONS

    Questions or Comments: 1-844-484-8372

  • Principal Display Package

    NDC# 72380-521-10

    soba®
    medical

    OPITOX®
    TOPICAL GEL

    PAIN RELIEF

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

    6 16728 00059 0

    SUGGESTED USE:
    Adults and Children 12 years of age
    and older: Rub a thin film over affected
    area(s) not more than four (4) times
    daily. Rinse hands with cool water after
    use. Use only as directed.
    Children under 12 years of age:
    Consult physician.

    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. Not for ophthalmic use.

    soba®
    medical

    Manufactured for:
    Soba Medical
    A subsidiary of Vivera Pharmaceuticals
    11100 Greenstone Ave. Santa Fe Springs, CA 90670
    www.opitox.com

    MADE IN USA REV11202019

    soba®
    medical

    OPITOX®
    TOPICAL GEL

    Retail Box

    OPITOX Box

    Tube

    OPITOX Tube

    Information Insert

    Opitox PiP

    res

  • INGREDIENTS AND APPEARANCE
    OPITOX TOPICAL  GEL
    menthol camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72380-521
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PAPRIKA (UNII: X72Z47861V)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72380-521-101 in 1 BOX08/06/2019
    188.7 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/06/2019
    Labeler - Vivera Pharmaceuticals, Inc. (081244342)