FDA.reportPublic FDA data

Modere Sports Rub

Manufacturer
Maple Mountain Group, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:23:06

Label at a glance#

ProductModere Sports Rub
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

adults and children 12 years and over : Apply to affected area not more than three to four times daily children under 12 years: consult a physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Menthol 5%..............Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or on mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present or irritation develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding,contact physician prior to use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over:Apply to affected area not more than three to four times daily
  • children under 12 years:consult a physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, butylene glycol, isopentyldiol, stearic acid, cetyl alcohol, glycerin, polyglyceryl-3 methylglucose distearate, copaifera officinalis (balsam copaiba) resin oil, dimethyl sulfone, sodium acrylate/sodium acryloyldimethyl taurate copolymer, zea mays (corn) oil, c15-19 alkane, lysine aspartate, mentha piperita (peppermint) oil, cetyl hydroxyethylcellulose, potassium sorbate, stearyl glycyyrrhetinate, 1,2-hexanediol, caprylyl glycol, tetrasodium glutamate diacetate, polyglyceryl-6 laurate, salix alba (willow) bark extract, yeast polysaccharides, arnica montana flower extract, polyglycerin-6, panax ginseng root extract, panax quinquefolius root extract, capsicum frutescens fruit extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MODERE

SPORTS RUB

menthol 5%

with skin-conditioning

white willow extract

125mL/4.2 FL OZ

11

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79400-10179400-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SALIX ALBA BARK205MXS71H7IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASIAN GINSENGCUQ3A77YXIIACT
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATEW19EIO0DBEIACT
GLYCERINPDC6A3C0OXIACT
C15-19 ALKANECI87N1IM01IACT
AMERICAN GINSENG8W75VCV53QIACT
TABASCO PEPPERJ1M3NA843LIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CORN OIL8470G57WFMIACT
STEARYL GLYCYRRHETINATE3YYE6VJS0PIACT
COPAIFERA OFFICINALIS RESIN1VH544O5ATIACT
PEPPERMINT OILAV092KU4JHIACT
LYSINE ASPARTATE23227F83U0IACT
ISOPENTYLDIOL19NOL5474QIACT
STEARIC ACID4ELV7Z65APIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
POLYGLYCERIN-6M51422LRAMIACT
MENTHOLL7T10EIP3AACTIB

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
08b6517d-c0e6-b4cf-e063-6394a90a6ab6c25233cd-4bda-1e1e-e053-2995a90af3bd2023-10-27WarningsExact identifier
spl id: 08b6517d-c0e6-b4cf-e063-6394a90a6ab6
spl set id: c25233cd-4bda-1e1e-e053-2995a90af3bd

Reported adverse events (FAERS/openFDA)#

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