FLEXSPORT ROLL ON- menthol cream
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

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)

FlexSport Rollon

FLEXSPORT ROLL ON
menthol cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55758-316-02	1 in 1 BOX	04/04/2019	04/30/2021
1		1 in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/04/2019	04/30/2021

Labeler - Pharmadel LLC (030129680)

Revised: 4/2021

Document Id: bf8edfa4-fe84-29ee-e053-2995a90aa8fe

Set id: 85b8ef3d-72fa-7f3b-e053-2991aa0a0777

Version: 4

Effective Time: 20210409

Pharmadel LLC