OPITOX TOPICAL GEL PAIN RELIEF
- Manufacturer
- Vivera Pharmaceuticals, Inc.
- Effective date
- 2019-12-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:01:47
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Menthol 3.5%
Camphor 0.2%
OTC - PURPOSE SECTION
Purpose
Menthol ............................Topical Analgesic
Camphor ..........................Topical Analgesic
INDICATIONS & USAGE SECTION
Uses: For temporary relief of minor aches and pains
of sore muscles and joints associated with:
• arthritis
• backache
• strains
• sprains
WARNINGS SECTION
Warnings: For external use only.
OTHER SAFETY INFORMATION
Flammable: Keep away from excessive heat or open flame.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have: Sensitive skin
OTC - WHEN USING SECTION
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 SECTION
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 SECTION
Keep out of reach of children: If accidentally
ingested, get medical help or contact a Poison Control
Center immediately.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding: Ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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 SECTION
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
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4d7a96d5-8256-4268-9a6c-25ea66d321fe | Product name | 1 | 20180814 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72380-521-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d2b4-a426-e053-dadaa90af4c2 | OPITOX TOPICAL GEL PAIN RELIEF |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72380-521-10 | OPITOX TOPICALGel | 1 in 1 BOX | GEL | 1 | 1 | |
| 72380-521-10 | OPITOX TOPICALGel | 88.7 mL in 1 TUBE | GEL | 88.7 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- OPITOX TOPICAL Gel
- MENTHOL CAMPHOR
- MENTHOL
- CAMPHOR (SYNTHETIC)
- ALCOHOL
- WATER
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- GLYCERIN
- CANNABIS SATIVA SEED OIL
- CANNABIDIOL
- ALOE VERA LEAF
- ARNICA MONTANA FLOWER
- PEPPERMINT OIL
- SPEARMINT OIL
- PROPYLENE GLYCOL
- HAMAMELIS VIRGINIANA LEAF
- TEA TREE OIL
- PAPRIKA
- GREEN TEA LEAF
- PHENOXYETHANOL
- CAPRYLIC ALCOHOL
- ETHYLHEXYLGLYCERIN
- HEXYLENE GLYCOL
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72380-521 | 72380-521-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 33849afb-7b97-49fb-b2c2-bd98f13fcacc | cb3de61a-b0b1-443b-8c11-438753ecb87a | 2019-12-05 | Warnings | 33849afb-7b97-49fb-b2c2-bd98f13fcacc cb3de61a-b0b1-443b-8c11-438753ecb87a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


