Neuriterx

Manufacturer
Semprae Laboratories Inc | Topical Pharmaceuticals Inc.
Effective date
2019-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:55

Label at a glance#

ProductNeuriterx
Active ingredientCAPSAICIN
Label structure11 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.075%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

• arthritis

• strains

• bruises

• sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store at 20° - 25°C (68° - 77°F)

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Neuriterx Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
141868capsaicin 0.075 % Topical CreamPSN1
141868capsaicin 0.75 MG/ML Topical CreamSCD1
141868capsaicin 0.075 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72826-130-142022-01-28C16284748780-1d6a99b39-ec7b-a426-e053-dadaa90af4c2Semprae Capsaicin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72826-130-14Neuriterx56.7 g in 1 CONTAINERCREAM56.71
72826-130-14Neuriterx1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72826-130NEURITERX (CAPSAICIN 0.075%) CREAM [SEMPRAE LABORATORIES INC]1Legacy NDC, 2 package rows20191211_5993d5ad-b949-4bb7-bc76-190477ed5df0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72826-13072826-130-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
80c91456-01ad-4e5f-b064-307b79e89ddf5993d5ad-b949-4bb7-bc76-190477ed5df02019-12-10WarningsExact identifier
spl id: 80c91456-01ad-4e5f-b064-307b79e89ddf
spl set id: 5993d5ad-b949-4bb7-bc76-190477ed5df0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.