Label: DICLOFENAC SODIUM gel

  • NDC Code(s): 72036-014-10, 72036-014-50
  • Packager: Harris Teeter
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 30, 2024

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  • Drug Facts
    Active ingredient - Diclofenac sodium USP (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug
  • Purpose
    Arthritis pain reliever
  • Uses
    for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for ...
  • Warnings
    For external use only - Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives - asthma (wheezing) skin ...
  • Do not use
    if you have ever had an allergic reaction to any other pain reliever or to a fever reducer - for strains, sprains, bruises or sports injuries. This product has not been shown to work for these ...
  • Ask a doctor before use if
    you have problems or serious side effects from taking pain relievers or fever reducers - stomach bleeding warning applies to you - you have a history of stomach problems, such as heartburn - you ...
  • Ask a doctor or pharmacist before use if you are
    under a doctor’s care for any serious condition - taking any other drug
  • When using this product
    avoid contact with eyes, nose, or mouth - if eye contact occurs, rinse thoroughly with water
  • Stop use and ask a doctor if
    pain gets worse or lasts more than 21 days - redness or swelling is present in the painful area - fever occurs - skin irritation occurs - any new symptoms appear. These could be signs of a serious ...
  • If pregnant or breast-feeding,
    ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause ...
  • Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions
    Use up to 21 days unless directed by your doctor - Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of ...
  • Other information
    store at 20° to 25°C (68° to 77°F). Keep from freezing. read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.
  • Inactive ingredients
    carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution - Questions ...
  • SPL UNCLASSIFIED SECTION
    DICLOFENAC SODIUM TOPICAL GEL, 1% Arthritis Pain - NSAID – Arthritis Pain Reliever - User Guide - How to use diclofenac sodium topical gel arthritis pain, with answers to frequently asked ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1% w/w Tube Carton Label (50 g tube)
    Harris Teeter™ ††Compare to Voltaren® Arthritis Pain - Active Ingredient - Diclofenac - Sodium - Topical Gel, 1% Arthritis Pain - NSAID - Arthritis Pain - Reliever - Original ...
  • INGREDIENTS AND APPEARANCE
    Product Information