NEURITERX- capsaicin 0.05% cream

Neuriterx by

Drug Labeling and Warnings

Neuriterx by is a Otc medication manufactured, distributed, or labeled by Innovus Pharmaceuticals, Inc., Topical Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Capsaicin 0.05%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:
simple backache

arthritis

strains

bruises

sprains

Warnings

For external use only

When using this product

use only as directed
do not bandage tightly
do not use with heating pad
avoid contact with eyes and mucous membranes
do not apply to wounds, damaged, broken or irritated skin
a transient burning sensation may occur upon application but generally disappears in several days
if severe burning sensation occurs, discontinue use immediately
do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if

Condition worsens

Redness is present

Irritation develops 

Symptoms persist for more than 7 days or symptoms clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 18 years:

Apply to affected area
Massage into painful area until thoroughly absorbed
Repeat as necessary, but no more than 3 to 4 times daily

Children 18 years or younger: ask a doctor

Other Information

Store at 20° - 25°C (68° - 77°F)

Do not use if inner container seal is damaged or missing.

Inactive Ingredients

Almond Oil, Benzyl Alcohol, Benzyl Benzoate, Butylated Hydroxytoluene, Carbomer Copolymer Type B, Cinnamon Bark Oil, Coriander Oil, Edetate Disodium, Isopropyl Alcohol, L-Arginine HCl, L-Citrulline , Polyoxl 40 Hydrogenated Castor Oil, Propylene Glycol, Sorbitol,Trolamine, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEURITERX 
capsaicin 0.05% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-221
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALMOND OIL (UNII: 66YXD4DKO9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZYL BENZOATE (UNII: N863NB338G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
CINNAMON BARK OIL (UNII: XE54U569EC)
CORIANDER OIL (UNII: 7626GC95E5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
CITRULLINE (UNII: 29VT07BGDA)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-221-01	1 in 1 CARTON	02/02/2021
1		56.7 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	02/02/2021

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Registrant - Innovus Pharmaceuticals, Inc. (962507187)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals Inc.		831530683	manufacture(57483-221)