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DRUG FACTS
Opitox Topical
FDA Label NDC 72380-521
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivera Pharmaceuticals, Inc. for the product Opitox Topical (NDC 72380-521). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, other safety information, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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