FLEXSPORT ROLL ON- menthol cream

FlexSport Roll On by

Drug Labeling and Warnings

FlexSport Roll On by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient and Purpose

• Active ingredient: Purpose
• Menthol 16% ....................: Topical analgesic

Uses

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

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

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

• use only as directed
• adults and children over 2 years: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store at temperatures not exceeding 15°–30°C(59°– 86°F)
• avoid excessive heat and humidity
• Do not use if clear shrink seal over cap is broken, torn or missing.
• save box for complete drug facts

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 Cream

FlexSport

Pain Relief

ROLL-ON

• Muscle & Joint Pain
• Backaches
• Arthritis

2.5 fl oz (74 mL)

INGREDIENTS AND APPEARANCE

FLEXSPORT ROLL ON 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIHYDROCAPSAICIN (UNII: W9BV32M08A)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-316-02	1 in 1 BOX	04/04/2019
1		1 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	04/04/2019

Labeler - Pharmadel LLC (030129680)