MOBISYN PAIN RELIEVING- methyl salicylate and menthol gel 
Chrono Health Care dba Natures Health Care

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Mobisyn Pain Relieving Gel

Drug Facts

Active Ingredients

Methyl salicylate 16%

Menthol 8%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

Warnings

For external use only.

When using this product

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

Stop use and ask a doctor if:

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:

Ask a health professional before use.

Keep out of reach of children:

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

Directions

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

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.

PDP

MOBISYN PAIN RELIEVING 
methyl salicylate and menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73799-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE16 mg  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM8 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WITCH HAZEL (UNII: 101I4J0U34)  
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73799-001-031 in 1 CARTON09/22/2020
190 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/22/2020
Labeler - Chrono Health Care dba Natures Health Care (014996415)
Establishment
NameAddressID/FEIBusiness Operations
Specialty Formulations and Manufacturing LLC003989912manufacture(73799-001)

Revised: 5/2020
Document Id: a5cb00d7-a452-6702-e053-2995a90af48a
Set id: a5cb00d7-a451-6702-e053-2995a90af48a
Version: 1
Effective Time: 20200516
 
Chrono Health Care dba Natures Health Care