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NDC 50383-0528-01 Diclofenac Sodium 10 mg/g Details
Diclofenac Sodium 10 mg/g
Diclofenac Sodium is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. The primary component is DICLOFENAC SODIUM.
MedlinePlus Drug Summary
Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known. Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph entitled diclofenac topical (osteoarthritis pain).
Related Packages: 50383-0528-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diclofenac Topical (actinic keratosis)
Product Information
| NDC | 50383-0528 |
|---|---|
| Product ID | 50383-528_0b7b1230-d848-4795-be3b-387d26eb2932 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Diclofenac Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diclofenac Sodium |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | DICLOFENAC SODIUM |
| Labeler Name | Akorn |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209484 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50383-0528-01 (50383052801)
| NDC Package Code | 50383-528-01 |
|---|---|
| Billing NDC | 50383052801 |
| Package | 1 TUBE in 1 CARTON (50383-528-01) / 100 g in 1 TUBE |
| Marketing Start Date | 2021-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0b7b1230-d848-4795-be3b-387d26eb2932 Details
Active ingredient
Uses
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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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
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.
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Daily |
Per Dose |
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For your arthritis pain:
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Use ENCLOSED DOSING CARD to measure a dose
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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
INGREDIENTS AND APPEARANCE
| DICLOFENAC SODIUM
diclofenac sodium gel |
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| Labeler - Akorn (117696873) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | MANUFACTURE(50383-528) , PACK(50383-528) | |