OPITOX 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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OPITOX TOPICAL GEL PAIN RELIEF

DRUG FACTS

Active Ingredients
Menthol 3.5%
Camphor 0.2%

Purpose
Menthol ............................Topical Analgesic
Camphor ..........................Topical Analgesic

Uses: For temporary relief of minor aches and pains
of sore muscles and joints associated with:
• arthritis
• 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; 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.

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.

Keep out of reach of children: If accidentally
ingested, get medical help or contact a Poison Control
Center immediately.

If pregnant or breast-feeding: Ask a health professional before use.

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

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

Questions or Comments: 1-844-484-8372

Principal Display Package

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 Box

Tube

OPITOX Tube

Information Insert

Opitox PiP

res

OPITOX TOPICAL  GEL
menthol camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72380-521
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)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SPEARMINT OIL (UNII: C3M81465G5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
TEA TREE OIL (UNII: VIF565UC2G)  
PAPRIKA (UNII: X72Z47861V)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLIC ALCOHOL (UNII: NV1779205D)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72380-521-101 in 1 BOX08/06/2019
188.7 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/06/2019
Labeler - Vivera Pharmaceuticals, Inc. (081244342)

Revised: 12/2019
Document Id: 33849afb-7b97-49fb-b2c2-bd98f13fcacc
Set id: cb3de61a-b0b1-443b-8c11-438753ecb87a
Version: 1
Effective Time: 20191205
 
Vivera Pharmaceuticals, Inc.