Rugged Fit Pain Relief Roll On
39d68734-981c-14d7-e063-6294a90a4919
HUMAN OTC DRUG LABEL
Aug 1, 2025
SYSTEM4BOOK LLC
DUNS: 096336844
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Menthol, Methyl Salicylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.
OTC - PURPOSE SECTION
Topical Analgesic
WARNINGS SECTION
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 productdo 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a poison control center right away.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Menthol 2%, Methyl Salicylate 10%