FDA.reportPublic FDA data

Mobisyn Pain Relieving Gel

Manufacturer
Chrono Health Care dba Natures Health Care | Specialty Formulations and Manufacturing LLC
Effective date
2020-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:39

Label at a glance#

ProductMobisyn Pain Relieving
Active ingredientMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

Adults and children over 12 years: Using the roll-on applicator, apply a thin layer to affected area. •Massage into painful area until thoroughly absorbed into skin. •Repeat as necessay, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications. AFTER APPLYING, WASH HANDS WITH SOAP AND WATER Children 12 years or younger: Ask doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl salicylate 16%

Menthol 8%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Use only as directed. •Read and follow all directions and warnings on this label.

  • Avoid contact with eyes or mucous membranes.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of application. •Do not apply to wounds or damaged, broken or irritated skin.
  • Wash hands after use.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

Condition worsens or syptoms persist for more than 7 days or symptoms clear up and occur again with a few days. Excessive skin irritation occurs.

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 accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

Using the roll-on applicator, apply a thin layer to affected area. •Massage into painful area until thoroughly absorbed into skin. •Repeat as necessay, but no more than 3 to 4 times daily, allowing a minimum of 2-3 hours between applications.

AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

Children 12 years or younger: Ask doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acryloyldimethyltaurate/VP Copolymer, Arnica Extract, Caprylic/Capric Triglyceride, Cis-9-Cetylmyristoleate (CMO), Ethanol, Glucosamine HCL, Glycerin, Methylsulfonylmethane (MSM), Phenoxyethanol (and) Ethylhexylglycerin, Polysorbate 20, Witch Hazel, and Purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2043919menthol 8 % / methyl salicylate 16 % Topical GelPSN1
2043919menthol 0.08 MG/MG / methyl salicylate 0.16 MG/MG Topical GelSCD1
2043919menthol 8 % / methyl salicylate 16 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73799-001-032022-01-28C16284748780-1d6a99b39-e354-a426-e053-dadaa90af4c2Mobisyn Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73799-001-03Mobisyn Pain Relieving1 in 1 CARTONGEL11
73799-001-03Mobisyn Pain Relieving90 mL in 1 BOTTLE, WITH APPLICATORGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73799-001MOBISYN PAIN RELIEVING (METHYL SALICYLATE AND MENTHOL) GEL [CHRONO HEALTH CARE DBA NATURES HEALTH CARE]1Legacy NDC, 2 package rows20201001_a5cb00d7-a451-6702-e053-2995a90af48a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73799-00173799-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYSORBATE 207T1F30V5YHIACT
WITCH HAZEL101I4J0U34IACT
CETYL MYRISTOLEATE87P8K33Q5XIACT

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
a5cb00d7-a452-6702-e053-2995a90af48aa5cb00d7-a451-6702-e053-2995a90af48a2020-05-16WarningsExact identifier
spl id: a5cb00d7-a452-6702-e053-2995a90af48a
spl set id: a5cb00d7-a451-6702-e053-2995a90af48a

Reported adverse events (FAERS/openFDA)#

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