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DRUG FACTS
Tvia Topical
FDA Label NDC 72380-728
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 Tvia Topical (NDC 72380-728). 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 from minor aches and
pains of sore muscles and joints associated with:
arthritis pain • 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 • 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
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
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
KEEP OUT OF REACH OF CHILDREN: If swallowed,
get medical help or contact a poison control center
immediately
Dosage & Administration
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.
Inactive Ingredient
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
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
Tube
Insert
TVIA Topical Gel by Vivera Pharmaceuticals, Inc.
res
* Please review the disclaimer below.
