FDA.reportPublic FDA data

NUMOTIZINE OINTMENT

Manufacturer
Hobart Laboratories, Inc.
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:57:07

Label at a glance#

ProductNUMOTIZINE
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For use as a topical analgesic Provides temporary relief of muscle pain, soreness and stiffness Temporary pain relief on strains, sprains, ligament and tendon injuries Arthritis

Dosage and administration

Stir in any liquid at top of jar. Keep sealed when not in use. Spread 1/8" to 1/4" of ointment to the skin. Cover the ointment with a cloth or bandage to protect clothing. Remove with warm water before totally dry (usually 8 to 12 hours). Application may be repeated every 12 hours as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Inactive ingredients

INACTIVE INGREDIENT SECTION

Clay, Color, Fragrance of Guaiacol, Methyl Guaiacol and Oil of Wintergreen, Polyols.

Directions

DOSAGE & ADMINISTRATION SECTION

Stir in any liquid at top of jar. Keep sealed when not in use.

Spread 1/8" to 1/4" of ointment to the skin. Cover the ointment with a cloth or bandage to protect clothing. Remove with warm water before totally dry (usually 8 to 12 hours). Application may be repeated every 12 hours as needed.

Uses

INDICATIONS & USAGE SECTION

For use as a topical analgesic

  • Provides temporary relief of muscle pain, soreness and stiffness
  • Temporary pain relief on strains, sprains, ligament and tendon injuries
  • Arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Excessive irritation of the skin occurs.
  • Persistent swellings.

Warnings:

WARNINGS SECTION

For external use only.

Use only as directed. Avoid contact with eyes and mucous memebranes.

Do not apply to irritated or broken skin or to large areas of the body.

Representative Labeling For - Numotizine Ointment 3.5oz/99g (10546-100-35) | Numotizine Ointment 8oz/228g (10546-100-08)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Numotizine8Numotizine8


NumotizineCartonNumotizineCarton


NumotizineCartonANumotizineCartonA

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1233196menthol 1.25 % Topical OintmentPSN8
1233201NUMOTIZINE 1.25 % Topical OintmentPSN8
1233201menthol 0.0125 MG/MG Topical Ointment [Numotizine]SBD8
1233196menthol 0.0125 MG/MG Topical OintmentSCD8
1233201Numotizine 0.0125 MG/MG Topical OintmentSY8
1233201Numotizine 1.25 % Topical OintmentSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10546-100-08NUMOTIZINE228 g in 1 JAROINTMENT2288
10546-100-35NUMOTIZINE99 g in 1 JAROINTMENT998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10546-100NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]8Current NDC, Legacy NDC, 2 package rows20231021_9a29ad1b-4ba3-403f-90c9-ee7582fe4535.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A4
MENTHOLACTIVE MOIETYL7T10EIP3A4
CREOSOLINACTIVE INGREDIENTW9GW1KZG6N4
GUAIACOLINACTIVE INGREDIENT6JKA7MAH9C4
KAOLININACTIVE INGREDIENT24H4NWX5CO4
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10546-10010546-100-35, 10546-100-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
KAOLIN24H4NWX5COIACT
GUAIACOL6JKA7MAH9CIACT
CREOSOLW9GW1KZG6NIACT
METHYL SALICYLATELAV5U5022YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
KAOLINKAOLIN24H4NWX5COPOWDER / TOPICAL10056 mgExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COPOWDER / TOPICAL10056 mgExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COSYSTEM / TOPICAL420 mgExact identifier — unii+route
6 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
6 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COSYSTEM / TOPICAL420 mgExact identifier — unii+route
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COPOWDER / TOPICAL10056 mgExact identifier — unii+route
6 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
6 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COSYSTEM / TOPICAL420 mgExact identifier — unii+route
6 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
NUMOTIZINEMENTHOLHobart Laboratories, Inc.9a29ad1b-4ba3-403f-90c9-ee7582fe45352023-10-20WarningsExact identifier
ndc (package): 10546-100-35
ndc (package): 10546-100-08
ndc (product): 10546-100
ndc11 (package): 10546010008
ndc11 (package): 10546010035
spl id: 082b1721-9122-222f-e063-6294a90a5ea7
spl set id: 9a29ad1b-4ba3-403f-90c9-ee7582fe4535

Reported adverse events (FAERS/openFDA)#

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