RUGGED FIT PAIN RELIEF ROLL ON- menthol, methyl salicylate gel

Rugged Fit Pain Relief Roll On by

Drug Labeling and Warnings

Rugged Fit Pain Relief Roll On by is a Otc medication manufactured, distributed, or labeled by SYSTEM4BOOK LLC, Maximsuramerica SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 3%, Methyl Salicylate 10%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

WARNINGS

For external use only.

Do not use on children under 12 years of age, with a heating pad (may blister skin), on wounds or damaged skin.

When using this product do not bandage tightly, avoid contact with the eyes or mucous membranes.

Stop use and ask a doctor if excessive irritation develops, symptoms last more than 7 days or clear up and occur again within a few days, condition worsens.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age or older: apply to affected area up to 3 to 4 times daily. Children under 12 years of age: consult a physician.

INACTIVE INGREDIENT

Water, alcohol, carbomer, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-40 Hydrogenated Caster Oil, Aesculus Hippocastanum Seed Extract, Centella Assiatica Leaf Extract, Arnica Montana Flowers Oil, Calendula Officinalis Flower Extract, Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGGED FIT PAIN RELIEF ROLL ON 
menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85826-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85826-040-10	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/27/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/27/2025

Labeler - SYSTEM4BOOK LLC (096336844)

Registrant - Maximsuramerica SAS (886586033)

Establishment
Name	Address	ID/FEI	Business Operations
Maximsuramerica SAS		886586033	manufacture(85826-040)