Active Ingredient
Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Motrin Arthritis Pain (NDC 50580-574). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, other, purpose, uses, warnings, allergy alert, liver warning, stomach bleeding warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)
Drug Facts
Arthritis pain reliever
If no pain relief in 7 days, stop use.
For external use only
Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains diclofenac. Liver damage may occur if you apply
This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless de-nitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
carbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, puri-ed water, strong ammonia solution
Call 1-800-962-5357 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com
NDC 50580-574-02
Original
Prescription
Strength
NEW!
Dierent Ingredient
Diclofenac Sodium
Motrin
®
ARTHRITIS PAIN
Diclofenac Sodium
Topical Gel, 1% (NSAID)
ARTHRITIS PAIN RELIEVER
Anti-inflammatory
For daily treatment of
arthritis pain
Fragrance
Free**
For external use only
NET WT. 3.53 OZ (100 g)
* Please review the disclaimer below.