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#

ProductOPITOX TOPICAL Gel
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure16 sections

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 BoxOPITOX Box

Tube

OPITOX TubeOPITOX Tube

Information Insert

Opitox PiPOpitox PiP

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416207camphor 0.2 % / menthol 3.5 % Topical GelPSN1
416207camphor 0.002 MG/MG / menthol 0.035 MG/MG Topical GelSCD1
416207camphor 0.2 % / menthol 3.5 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72380-521-102022-01-28C16284748780-1d6a99b39-d2b4-a426-e053-dadaa90af4c2OPITOX TOPICAL GEL PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72380-521-10OPITOX TOPICALGel1 in 1 BOXGEL11
72380-521-10OPITOX TOPICALGel88.7 mL in 1 TUBEGEL88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72380-521OPITOX TOPICAL GEL (MENTHOL CAMPHOR) GEL [VIVERA PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20191206_cb3de61a-b0b1-443b-8c11-438753ecb87a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72380-52172380-521-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33849afb-7b97-49fb-b2c2-bd98f13fcacccb3de61a-b0b1-443b-8c11-438753ecb87a2019-12-05WarningsExact identifier
spl id: 33849afb-7b97-49fb-b2c2-bd98f13fcacc
spl set id: cb3de61a-b0b1-443b-8c11-438753ecb87a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.