1. Home
  2. Labeler Index
  3. Vivera Pharmaceuticals, Inc.
  4. 72380-521
  5. Label Information: Opitox Topical Gel

FDA Label for Opitox Topical Gel

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTHER SAFETY INFORMATION
    7. OTC - ASK DOCTOR
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. DOSAGE & ADMINISTRATION
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PACKAGE

Opitox Topical Gel Product Label

The following document was submitted to the FDA by the labeler of this product Vivera Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DRUG FACTS


Otc - Active Ingredient



Active Ingredients
Menthol 3.5%
Camphor 0.2%


Otc - 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.

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


Otc - Ask Doctor



Ask a doctor before use if you have: Sensitive skin


Otc - 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.


Otc - 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.


Otc - 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.


Otc - 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


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


Otc - 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

Tube

Information Insert

res


* Please review the disclaimer below.