TVIA GEL

Manufacturer
Vivera Pharmaceuticals, Inc.
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:47

Label at a glance#

ProductTVIA TOPICAL Gel
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure15 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 from minor aches and
pains of sore muscles and joints associated with:
arthritis pain • 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 • Do not use with other
sprays, ointments, creams or liniments • Do not apply
to irritated skin, & discontinue use if excessive skin
irritation develops • Do not bandage • Do not use
with heating pads or device.

OTC - STOP USE SECTION

Stop use and contact your physician if: conditions
worsen, or if symptoms persist for more than seven (7)
days, or clear up and reoccur.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding: Ask a health
professional before use. Children under 2 years of age:
Consult physician

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN: If swallowed,
get medical help or contact a poison control center
immediately

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Use only as directed. Rub a thin film
over the affected areas not more than four (4) times
daily. Rinse hands after use with cool water.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol Denatured,
Deionized Water, Glycerin, Propylene Glycol, Cannabis
Sativa Seed Oil (Hemp Seed Oil), Cannabidiol (CBD), Arnica
Montana Flower Extract (Arnica Oil), Mentha Piperita
(Peppermint) Oil, Carbomer, Triethanolamine, Mentha Viridis
(Spearmint) Leaf Oil, Camellia Sinensis Leaf Extract, Aloe
Barbadensis Leaf Extract, Hamamelis Virginiana (Witch
Hazel) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil,

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 72380-728-10

VIVERA®
PHARMACEUTICALS

TVIA GEL®
T O P I C A L   G E L

PAIN RELIEF

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

6 16728 00071 2

TVIA GEL®
T O P I C A L   G E L

SUGGESTED USE: Apply a
small amount topically to
affected area and rub in. Use
every 4 to 6 hours. Safe for
use on adults over 21 years
of age. Wash hands with cool
water after each use.

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. This product has
not been evaluated by the
Food and Drug Administration.

VIVERA®
PHARMACEUTICALS

*These statements have not been
evaluated by the Food and Drug
Administration. This product is not
intended to diagnose, treat, cure or
prevent any disease.

VIV-71000-GBX          REV20190115

VIVERA®
PHARMACEUTICALS

Manufacrured For:
Vivera Pharmaceuticals, Inc.
11100 Greenstone Ave
Santa Fe Springs, CA 90670

MADE IN USA

Retail Box

TVIA Box 3ozTVIA Box 3oz

Tube

TVIA tubeTVIA tube

Insert

TVIA insertTVIA insert

                                                TVIA Topical Gel by Vivera Pharmaceuticals, Inc.

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416207camphor 0.2 % / menthol 3.5 % Topical GelPSN2
2109250TVIA 0.2 % / 3.5 % Topical GelPSN2
2109250camphor 0.002 MG/MG / menthol 0.035 MG/MG Topical Gel [Tvia]SBD2
416207camphor 0.002 MG/MG / menthol 0.035 MG/MG Topical GelSCD2
416207camphor 0.2 % / menthol 3.5 % Topical GelSY2
2109250Tvia (camphor 0.2 % / menthol 3.5 % ) Topical GelSY2

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
72380-728-102022-01-28C16284748780-1d6a99b39-6b4d-a426-e053-dadaa90af4c2TVIA GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72380-728-10TVIA TOPICALGel1 in 1 BOXGEL12
72380-728-10TVIA TOPICALGel88.7 mL in 1 PACKETGEL88.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72380-728TVIA TOPICAL GEL (MENTHOL, CAMPHOR) GEL [VIVERA PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20191206_cbeaddd7-6371-4b50-a940-7648edfacd34.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
72380-72872380-728-10

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
0ee63f06-b660-406b-97d8-21b7b2329cf7cbeaddd7-6371-4b50-a940-7648edfacd342019-12-05WarningsExact identifier
spl id: 0ee63f06-b660-406b-97d8-21b7b2329cf7
spl set id: cbeaddd7-6371-4b50-a940-7648edfacd34

Reported adverse events (FAERS/openFDA)#

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