OPITOX TOPICAL GEL- menthol camphor gel

OPITOX TOPICAL by

Drug Labeling and Warnings

OPITOX 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 of minor aches and pains
of sore muscles and joints associated with:
arthritis
backache
strains
sprains

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; 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

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

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

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

Tube

Information Insert

res

INGREDIENTS AND APPEARANCE

OPITOX TOPICAL  GEL
menthol camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72380-521
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72380-521-10	1 in 1 BOX	08/06/2019
1		88.7 mL in 1 TUBE; 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	08/06/2019

Labeler - Vivera Pharmaceuticals, Inc. (081244342)