FDA.reportPublic FDA data

NuDroxicin pain relief Roll-On

Manufacturer
NuCare Pharmaceuticals Inc
Effective date
2018-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:23

Label at a glance#

ProductNuDroxicin pain relief Roll-On
Active ingredientMETHYL SALICYLATE, MENTHOL, CAPSAICIN
Label structure6 sections

Indications and uses

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Dosage and administration

Shake before each use. Prior to first use rub small amount to check for sensitivity. Apply product directly to affected area. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Product may be used as necessary, but should not be used more than four times per day. STORE BELOW (90°F/32°C)

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25.00%
Menthol 6.00% 
Capsaicin 0.025%

OTC - PURPOSE SECTION

Topical Analgesic

USES:

INDICATIONS & USAGE SECTION

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

WARNINGS:

WARNINGS SECTION

  • For external use only. Use only as directed. Avoid contact with eyes and mucous  membranes or genitals.
  • Do not cover or tightly bandage area.
  • on wounds or damaged skin.
  • Do not use with heating pad.

Do not use

OTC - DO NOT USE SECTION

On cuts or infected skin, on children less than 12 years old in large amount.

STOP USE AND ASK A PHYSICIAN:

OTC - STOP USE SECTION

For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If itching or rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Consult physician for children under 12.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Shake before each use. Prior to first use rub small amount to check for sensitivity. Apply product directly to affected area. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Product may be used as necessary, but should not be used more than four times per day.

STORE BELOW (90°F/32°C)

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Beeswax, Boswellia Serrata Extract, Carbomer, Cetearyl Olivate, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Sorbitan Olivate, Triethanolamine

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1989491capsaicin 0.025 % / menthol 6 % / methyl salicylate 25 % Topical SolutionPSN2
1989491capsaicin 0.25 MG/ML / menthol 60 MG/ML / methyl salicylate 250 MG/ML Topical SolutionSCD2
1989491capsaicin 0.025 % / menthol 6 % / methyl salicylate 25 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70859-028-032024-01-30C16284748780-11030e365-47e8-111a-e063-dadaa90a10e2NuDroxicin pain relief Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70859-028-03NuDroxicin pain relief Roll-On90 mL in 1 CONTAINERLIQUID902
70859-028-03NuDroxicin pain relief Roll-On1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70859-028NUDROXICIN PAIN RELIEF ROLL-ON (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LIQUID [NUCARE PHARMACEUTICALS INC]2Legacy NDC, 2 package rows20180207_6492c511-c483-c337-e053-2a91aa0a3916.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70859-028-03ML - Milliliter70859-0289b0c060c-caec-4924-b4aa-7d75a275772b12018-02-20

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70859-02870859-028-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
YELLOW WAX2ZA36H0S2VIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETEARYL OLIVATE58B69Q84JOIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN OLIVATEMDL271E3GRIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

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
6492c511-c484-c337-e053-2a91aa0a39166492c511-c483-c337-e053-2a91aa0a39162018-02-06WarningsExact identifier
spl id: 6492c511-c484-c337-e053-2a91aa0a3916
spl set id: 6492c511-c483-c337-e053-2a91aa0a3916

Reported adverse events (FAERS/openFDA)#

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