FDA.reportPublic FDA data

SmartRx Natural Pain Relief Sleeve ANKLE

Manufacturer
Niche Brands, Inc. | AB7 Industries
Effective date
2013-12-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:55

Label at a glance#

ProductSmartRx Natural Pain Relief Sleeve ANKLE
Active ingredientMETHYL SALICYLATE
Label structure9 sections

Dosage and administration

Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area. Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 3 years of age: Consult a physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 10%

Purpose

OTC - PURPOSE SECTION

External Analgesic (Counterirritant)

Use

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with • arthritis • strains • bruises • sprains.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

When using this product

OTC - WHEN USING SECTION

  • Do not use otherwise than as directed.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use in conjunction with liniments, balms or lotions.
  • Do not use on damaged or broken skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Redness is present.
  • Excessive irritation of skin develops.
  • Condition worsens, or if symptoms persist for more than 7 days.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Open pouch and remove. Pull woven sleeve containing external analgesic pads over ankle, positioning on either side of affected area.

  • Adults and children 3 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 3 years of age: Consult a physician.

Other information:

SPL UNCLASSIFIED SECTION

  • Store away from direct sunlight.
  • For your protection, this sleeve has been sealed in an aluminum pouch.
  • Do not use if tamper evident seal is missing, tampered, broken or destroyed.

Allergy warning:

SPL UNCLASSIFIED SECTION

Contains Macadamia nut oil.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Macadamia nut oil, citronella oil, mandarin oil, coriander oil and rosemary oil.

Questions?:

OTC - QUESTIONS SECTION

000-000-0000

SmartRx Natural Pain Relief Sleeve ANKLE 1 count (60589-001-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ankle SleeveAnkle Sleeve

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1485642methyl salicylate 10 % Medicated PadPSN1
1485648SMARTRX 10 % Medicated PadPSN1
1485648methyl salicylate 0.1 MG/MG Medicated Pad [Smartrx]SBD1
1485642methyl salicylate 0.1 MG/MG Medicated PadSCD1
1485642methyl salicylate 10 % Medicated PadSY1
1485648Smartrx (methyl salicylate 10 % ) Medicated PadSY1
1485648Smartrx 0.1 MG/MG Medicated PadSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60589-001-002019-11-27C16284748780-19855e2a2-4ecc-60a7-e053-dbdaa90a05bdSmartRx Natural Pain Relief Sleeve ANKLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60589-001-00SmartRx Natural Pain Relief Sleeve ANKLE1 in 1 BOXLIQUID11
60589-001-00SmartRx Natural Pain Relief Sleeve ANKLE0.2 g in 1 PACKAGELIQUID0.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60589-001SMARTRX NATURAL PAIN RELIEF SLEEVE ANKLE (METHYL SALICYLATE) LIQUID [NICHE BRANDS, INC.]1Legacy NDC, 2 package rows20131230_9f17d8ef-1a59-4ad7-800e-9bc8d223ccdb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
CITRONELLA OILINACTIVE INGREDIENTQYO8Q067D01
CORIANDER OILINACTIVE INGREDIENT7626GC95E51
MACADAMIA OILINACTIVE INGREDIENT515610SU8C1
MANDARIN OILINACTIVE INGREDIENTNJO720F72R1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3931

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60589-00160589-001-00

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
METHYL SALICYLATELAV5U5022YACTIB
MACADAMIA OIL515610SU8CIACT
CITRONELLA OILQYO8Q067D0IACT
MANDARIN OILNJO720F72RIACT
CORIANDER OIL7626GC95E5IACT
ROSEMARY OIL8LGU7VM393IACT

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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CORIANDER OILCORIANDER OIL7626GC95E5LIQUID / ORAL2.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
CORIANDER OILCORIANDER OIL7626GC95E5ELIXIR / ORAL0.03 mgExact identifier — unii candidate
3 equally ranked IID candidates
CORIANDER OILCORIANDER OIL7626GC95E5DROPS / ORAL0.15 mg/1mlExact identifier — unii candidate
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
09d74dce-91c6-4283-abcb-839e274310079f17d8ef-1a59-4ad7-800e-9bc8d223ccdb2013-12-27WarningsExact identifier
spl id: 09d74dce-91c6-4283-abcb-839e27431007
spl set id: 9f17d8ef-1a59-4ad7-800e-9bc8d223ccdb

Reported adverse events (FAERS/openFDA)#

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