Label: DICLOFENAC SODIUM gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50383-528-01 - Packager: Akorn
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
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- hives
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- asthma (wheezing)
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- skin reddening
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- blisters
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- facial swelling
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- shock
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- rash
If an allergic reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains diclofenac. Liver damage may occur if you apply
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- more or for a longer time than directed
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- when using other drugs containing diclofenac
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- apply more or for longer than directed
Heart attack and stroke warning: 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.
Do Not Use
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- if you have ever had an allergic reaction to any other pain reliever or to a fever reducer
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- for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.
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- right before or after heart surgery
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- on more than 2 body areas at the same time
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- in the eyes, nose or mouth
Ask a doctor before use if
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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- you are taking a diuretic
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- you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.
Ask a doctor or pharmacist before use if you are
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- under a doctor’s care for any serious condition
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- taking any other drug
When using this product
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- avoid contact with eyes, nose, or mouth
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- If eye contact occurs, rinse thoroughly with water
Stop use and ask a doctor if
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- pain gets worse or lasts more than 21 days
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- redness or swelling is present in the painful area
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- fever occurs
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- skin irritation occurs
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- any new symptoms appear. These could be signs of a serious condition.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- have bloody or black stools
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- vomit blood
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- leg swelling
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- weakness in one part or side of body
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- slurred speech
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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 injuries.
Daily
Per Dose
For your arthritis pain:
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- Use 4 times per day every day
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- Do not use on more than 2 body areas at the same time
Use ENCLOSED DOSING CARD to measure a dose
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- For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams)
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- For each lower body areas (foot, ankle, or knee) – Squeeze out 4.5 inches (4 grams)
Read the enclosed User Guide for complete instructions.
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- use only as directed
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- do not use more than directed or for longer than directed
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- apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes
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- do not apply in same area as any other product
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- do not apply with external heat such as heating pad
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- do not apply a bandage over the treated area
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- store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.
- Other information
- Inactive Ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
DICLOFENAC SODIUM
diclofenac sodium gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-528 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM 10 mg in 1 g Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ISOPROPYL ALCOHOL (UNII: ND2M416302) MINERAL OIL (UNII: T5L8T28FGP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (Opaque) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50383-528-01 1 in 1 CARTON 12/31/2021 1 100 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209484 12/31/2021 Labeler - Akorn (117696873) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696873 MANUFACTURE(50383-528) , PACK(50383-528)
