Diclofenac Sodium 16.05 mg/mL
Diclofenac Sodium · SOLUTION · Direct_Rx
Diclofenac Sodium is a solution containing diclofenac sodium at 16.05 mg/mL, taken topical. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Diclofenac Sodium
- Generic Name
- Diclofenac Sodium
- NDC Code (Product)
72189-527- Manufacturer
- Direct_Rx
- Strength
- 16.05 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA206116
- Marketing Start
- 12/11/2023
Recall History
Actavis Inc
Failed Tablet/Capsule Specifications: Broken tablets
Direct Rx
Defective Container: Leaking containers.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Cipla USA, Inc.
Failed PH Specifications
Altaire Pharmaceuticals, Inc.
Lack of Assurance of Sterility
Actavis Laboratories, FL, Inc.
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Physicians Total Care, Inc.
Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.
Teligent Pharma, Inc.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Actavis Laboratories, FL, Inc.
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Watson Laboratories, Inc.-(Actavis) - Florida
Failed Tablet/Capsule Specifications: Broken tablets
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Dosage & Administration
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: Use 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle or knee) –Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.
Warnings
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 reddening blisters facial swelling shock 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 more or for a longer time than directed 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 are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product 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 if you have ever had a…
Frequently Asked Questions
What is Diclofenac Sodium used for?
Diclofenac Sodium contains Diclofenac Sodium. It is a solution taken topical. Consult your doctor for specific uses.
Is Diclofenac Sodium a controlled substance?
Diclofenac Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Diclofenac Sodium?
The generic name for Diclofenac Sodium is Diclofenac Sodium. There are 7 other brand versions of Diclofenac Sodium.
What is the NDC code for Diclofenac Sodium 16.05 mg/mL?
The NDC (National Drug Code) for Diclofenac Sodium 16.05 mg/mL is 72189-527, listed by Direct_Rx.