MOBISYN PAIN RELIEVING- methyl salicylate and menthol gel

Mobisyn Pain Relieving by

Drug Labeling and Warnings

Mobisyn Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Chrono Health Care dba Natures Health Care, Specialty Formulations and Manufacturing LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Methyl salicylate 16%

Menthol 8%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

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

Warnings

For external use only.

When using this product

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:

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOBISYN PAIN RELIEVING 
methyl salicylate and menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73799-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	16 mg  in 100 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	8 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73799-001-03	1 in 1 CARTON	09/22/2020
1		90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/22/2020

Labeler - Chrono Health Care dba Natures Health Care (014996415)

Establishment
Name	Address	ID/FEI	Business Operations
Specialty Formulations and Manufacturing LLC		003989912	manufacture(73799-001)