FLEXDERMAL PAIN RELIEVING ROLL-ON- menthol liquid

FlexDermal Pain Relieving Roll-On by

Drug Labeling and Warnings

FlexDermal Pain Relieving Roll-On by is a Otc medication manufactured, distributed, or labeled by SOLVADERM LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Menthol 2.00%

Purpose

Topical Analgesic

Uses

• For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.

Warnings

For external use only

Do not 

• apply to wounds or damaged skin.
• bandage tightly.

When using this product

• Avoid contact with the eyes.

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: consult a doctor.

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1 (CI 42090), Camphor, Ethylhexylglycerin, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Sodium Hydroxide, Water(Aqua)

Questions?

888-211-8468

Package Labeling:

INGREDIENTS AND APPEARANCE

FLEXDERMAL PAIN RELIEVING ROLL-ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84197-867
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84197-867-00	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/24/2025

Labeler - SOLVADERM LLC (093262409)