TVIA TOPICAL GEL- menthol, camphor gel 
Vivera Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TVIA GEL

DRUG FACTS

ACTIVE INGREDIENTS
Menthol 3.5%
Camphor 0.2%

PURPOSE
Menthol ............................Topical Analgesic
Camphor ..........................Topical Analgesic

USES: For temporary relief from minor aches and
pains of sore muscles and joints associated with:
arthritis pain • backache • strains • sprains

WARNINGS: For external use only.

Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have: Sensitive skin

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

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: If swallowed,
get medical help or contact a poison control center
immediately

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

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

TVIA Box 3oz

Tube

TVIA tube

Insert

TVIA insert

                                                TVIA Topical Gel by Vivera Pharmaceuticals, Inc.

res

TVIA TOPICAL  GEL
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72380-728
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72380-728-101 in 1 BOX12/01/2018
188.7 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/2018
Labeler - Vivera Pharmaceuticals, Inc. (081244342)

Revised: 12/2019
Document Id: 0ee63f06-b660-406b-97d8-21b7b2329cf7
Set id: cbeaddd7-6371-4b50-a940-7648edfacd34
Version: 2
Effective Time: 20191205
 
Vivera Pharmaceuticals, Inc.