Label: DICLOFENAC SODIUM gel
- NDC Code(s): 80425-0233-1
- Packager: Advanced Rx Pharmacy of Tennessee, LLC
- 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 February 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Indications and Usage
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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 contain an NSAID, which may cause severe stomach bleeding. The chance is small but high 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 non-prescription 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 attach, heart failure, and stroke. These can be fatal. The rish is higher if you use more than directed or for longer than directed.
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Do Not Use
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 types of injuries.
- right before or after heart surgery
- on more than 2 body areas at the same time
- in the eyes, nose or mouth
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Ask Doctor
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 or you have a history of stomach prohlems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you are under the age of 18 years. It is not known if this drug works or is safe in children under age 18 years.
- Ask Doctor/Pharmacist
- When Using
-
Stop Use
Stop 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 be signs of a serious condition.
- you experience any of the following signs of stomach bleeding
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heat problems or stroke
- chest pain
- trouble breathing
- leg swelling
- weakness in one part or side of body
- slurred speech
- Pregnancy or Breast Feeding
- Keep Out of Reach of Children
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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 For arthritis pain:
Use 4 times per day every day
Do not use on more than 2 body areas at the same time- Per Dose (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 the same area as any other product
do not apply with external heat such as heating pad
do not apply a bandage over the treated areastore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% Arthritis Pain. The dosing card is re-usable.
- Other Safety Information
- Inactive Ingredients
- Questions and Comments
- 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:80425-0233(NDC:70512-106) 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 WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) AMMONIA (UNII: 5138Q19F1X) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80425-0233-1 1 in 1 CARTON 02/06/2023 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 ANDA210986 02/06/2023 Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142) Establishment Name Address ID/FEI Business Operations Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0233)