Label: CRCLE DICLOFENAC SODIUM TOPICAL GEL 1%- diclofenac sodium topical gel 1% gel
- NDC Code(s): 57483-596-01
- Packager: Innovus Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 24, 2023
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- Active ingredient
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.
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 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 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 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
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 you have a history of stomach problems, 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 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
- When using this product
Stop use and ask a doctor if
- pain gets worse or lasts 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 heart problems or stroke
- chest pain
- trouble breathing
- leg swelling
- weakness in one part or side of body
- slurred speech
- If pregnant or breast-feeding
- Keep out of reach of children.
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% Arthritis Pain. The dosing card is re-usable.
- Other information
- Inactive ingredients
- Question and comments?
INGREDIENTS AND APPEARANCE
CRCLE DICLOFENAC SODIUM TOPICAL GEL 1%
diclofenac sodium topical gel 1% gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-596 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 CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) ISOPROPYL ALCOHOL (UNII: ND2M416302) MINERAL OIL (UNII: T5L8T28FGP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) AMMONIA (UNII: 5138Q19F1X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-596-01 1 in 1 CARTON 03/31/2023 1 150 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 01/10/2022 Labeler - Innovus Pharmaceuticals Inc. (962507187)