Label: DICLOFENAC SODIUM- diclofenac sodium 1% gel
- NDC Code(s): 76420-691-01
- Packager: Asclemed USA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 70512-106
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 29, 2025
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT(NSAID) - arthritis pain reliever - Active ingredient - Diclofenac sodium (NSAID*) 1% *nonsterodial anti-inflammatory drug
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PURPOSEPurpose - Arthritis pain reliever
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INDICATIONS & USAGEUses - for the temporary relief of arthritis pain - ONLYin the following areas: – hand, wrist, elbow (upper body areas) – foot, ankle, knee (lower body areas) This product may take up ...
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WARNINGSWarnings - 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) ...
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DO NOT USEDo 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 ...
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ASK DOCTORAsk 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 or you have a history of stomach ...
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ASK DOCTOR/PHARMACISTAsk a doctor or pharmacist before use if you are - under a doctor's care for any serious condition - taking any other drug
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WHEN USINGWhen using this product - avoid contact with eyes, nose, or mouth - if eye contact occurs, rinse thoroughly with water
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STOP USEStop use and ask a doctor if - pain gets worse or last more than 21 days - redness or swelling is present in the painful area - fever occurs - skin irritation occurs - any new symptoms appear. These could ...
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PREGNANCY OR BREAST FEEDINGIf pregnant or breast-feeding - ask a health care professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do ...
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KEEP OUT OF REACH OF CHILDRENKeep our of reach of children - If swallowed, get medical help or contact a Poison Control Center right away.
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DOSAGE & ADMINISTRATIONDirections - 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 injuries. Daily For ...
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OTHER SAFETY INFORMATIONOther Information - Store at 20-25°C (68°F - 77°F). Keep from freezing. read all product information before using. Keep the dossing card, the carton and accomanying User guide for important ...
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INACTIVE INGREDIENTInactive ingredients - Carbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia ...
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QUESTIONSQuestions and comments 1-866-747-7365
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PRINCIPAL DISPLAY PANELPrincipal Display Panel
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INGREDIENTS AND APPEARANCEProduct Information