TVIA TOPICAL GEL- menthol, camphor gel

TVIA TOPICAL by

Drug Labeling and Warnings

TVIA TOPICAL by is a Otc medication manufactured, distributed, or labeled by Vivera Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

ACTIVE INGREDIENTS
Menthol 3.5%
Camphor 0.2%

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 AND PRECAUTIONS

WARNINGS

WARNINGS: For external use only.

OTHER SAFETY INFORMATION

Flammable: Keep away from excessive heat or open flame.

ASK DOCTOR

Ask a doctor before use if you have: Sensitive skin

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.

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.

PREGNANCY OR BREAST FEEDING

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

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.

OTHER SAFETY INFORMATION

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

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

INGREDIENTS AND APPEARANCE

TVIA TOPICAL  GEL
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72380-728
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANNABIDIOL (UNII: 19GBJ60SN5)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
SPEARMINT OIL (UNII: C3M81465G5)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
TEA TREE OIL (UNII: VIF565UC2G)
PAPRIKA (UNII: X72Z47861V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLIC ALCOHOL (UNII: NV1779205D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72380-728-10	1 in 1 BOX	12/01/2018
1		88.7 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2018

Labeler - Vivera Pharmaceuticals, Inc. (081244342)