Label: ARTHRITIS PAIN RELIEVER- diclofenac sodium gel
- NDC Code(s): 68016-171-00, 68016-171-50
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 10, 2023
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- Medication Guide: HTML
- 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:
- 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 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 the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.
Ask a doctor or pharmacist before use if
- under a doctor’s care for any serious condition
- taking any other drug
When using this product
- avoid contact with eyes, nose, or mouth
- if eye contact occurs, rinse thoroughly with water
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 of side of body
- 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:
- 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 areas as any other product
- do not apply with external heat such as a heating pad
- do not apply a bandage over the treated area
- store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.
- Other information
- Inactive ingredients
- Questions or comments?
-
Med Guide
Use enclosed dosing card to measure a dose
Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever
Dosing Card (NOT ACTUAL SIZE)
Read product User Guide before use Not for immediate pain relief
[Upper body dose 2.25 inches long (2 grams)]
[Lower body dose 4.5 inches long (4 grams)
How to use
- For arthritis pain only
- Use 4 times a day
- May take up to 7 days to work for your arthritis pain
- For use on no more than 2 body areas
- Use up to 21 days unless directed by a doctor
-
Principal display panel
†COMPARE TO THE ACTIVE INGREDIENT IN VOLTAREN® ARTHRITIS PAIN TOPICAL GEL
ORIGINAL PRESCRIPTION STRENGTH
Arthritis Pain Relieving Gel
DICLOFENAC SODIUM TOPICAL GEL, 1% (NSAID)
- Medicated Gel Clinically Proven to Relieve Arthritis Pain
- For Daily Treatment of Arthritis Pain
- Anti-inflammatory
- For External Use only
NET WT OZ (g)
†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,, distributor of Voltaren® Arthritis Pain Topical Gel.
Treatment areas: Hand, Wrist, Elbow, Foot, Ankle, Knee
Not for use on any other body area (such as back, hip, or shoulder)
TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING.
Distributed by: Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087
- Package Label
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INGREDIENTS AND APPEARANCE
ARTHRITIS PAIN RELIEVER
diclofenac sodium gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-171 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) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-171-50 1 in 1 CARTON 12/31/2022 1 50 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68016-171-00 1 in 1 CARTON 12/31/2022 2 100 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 ANDA208077 12/31/2022 Labeler - Chain Drug Consortium, LLC (101668460)
