FLEXSPORT ROLL ON- methyl salicylate liquid 
Pharmadel LLC

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.

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FlexSport Roll On - MS 15%

Drug Facts

Active ingredient and Purpose

Active ingredientPurpose
Menthol 16% ....................Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Warnings

For external use only. Avoid contact with the eyes.

Flammable: keep away from fire or flame.

When using this product

  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor if

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water

Questions or Comments?

1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.com

Principal Display Panel

Topical Analgesic Liquid

FlexSport

Pain Relief

ROLL-ON

3 fl oz (89 mL)

FS PDP

FLEXSPORT ROLL ON 
methyl salicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
TROLAMINE (UNII: 9O3K93S3TK)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
CAPSAICIN (UNII: S07O44R1ZM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MENTHOL (UNII: L7T10EIP3A)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-360-031 in 1 BOX04/04/2021
189 g 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 finalpart34804/04/2021
Labeler - Pharmadel LLC (030129680)

Revised: 4/2021
Document Id: bf8de3da-762a-6112-e053-2995a90a8e16
Set id: bf8de3da-7628-6112-e053-2995a90a8e16
Version: 1
Effective Time: 20210409
 
Pharmadel LLC