Diclofenac Sodium 1 Percent Gel Aml

Diclofenac Sodium 1 Percent Gel Aml
SPL v3
SPL
SPL Set ID 98f94aa2-6bc2-4c07-81c8-63b2c262cf39
Route
TOPICAL
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diclofenac (10 mg)
Inactive Ingredients
Carbomer Homopolymer Type C Coco-caprylate/caprate Isopropyl Alcohol Mineral Oil Polyoxyl 20 Cetostearyl Ether Propylene Glycol Water Ammonia

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2024-08-01

Description

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug

Purpose

Arthritis Pain Reliever


Medication Information

Purpose

Arthritis Pain Reliever

Description

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug

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
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.

Med Guide

Use enclosed dosing card to measure a dose

Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever

[Upper body dose 2.25 inches long (2 grams)] Dosing Card (NOT ACTUAL SIZE)

[Lower body dose 4.5 inches long (4 grams) Read product User Guide before use Not for immediate pain relief

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
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.


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

Package Label
QUALITY CHOICE Arthritis Pain Reliever
Active Ingredient

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inflammatory drug

Other Information
  • store at 20° to 25°C (68° to 77°F). Keep from freezing.
  • read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information

Inactive Ingredients

carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

Questions Or Comments?

Call 1-800-935-2362 Monday-Friday 9 AM- 5 PM EST

Principal Display Panel

†Compare to the Active Ingredient in Voltaren® Arthritis Pain Topical Gel

ORIGINAL PRESCRIPTION STRENGTH

Diclofenac Sodium Topical Gel, 1% (NSAID)

Arthritis Pain Reliever

  • 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.

TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING.

Distributed by CDMA, Inc.

Novi, MI 48375

When Using This Product
  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water

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.

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
Keep Out of Reach of Children

 If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in  pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Ask A Doctor Or Pharmacist Before Use If
  • under a doctor’s care for any serious condition
  • taking any other drug


Structured Label Content

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
Purpose

Arthritis Pain Reliever

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.

Med Guide

Use enclosed dosing card to measure a dose

Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever

[Upper body dose 2.25 inches long (2 grams)] Dosing Card (NOT ACTUAL SIZE)

[Lower body dose 4.5 inches long (4 grams) Read product User Guide before use Not for immediate pain relief

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
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.


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

Package Label
QUALITY CHOICE Arthritis Pain Reliever
Active Ingredient (Active ingredient)

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inflammatory drug

Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F). Keep from freezing.
  • read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

Questions Or Comments? (Questions or comments?)

Call 1-800-935-2362 Monday-Friday 9 AM- 5 PM EST

Principal Display Panel (Principal display panel)

†Compare to the Active Ingredient in Voltaren® Arthritis Pain Topical Gel

ORIGINAL PRESCRIPTION STRENGTH

Diclofenac Sodium Topical Gel, 1% (NSAID)

Arthritis Pain Reliever

  • 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.

TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING.

Distributed by CDMA, Inc.

Novi, MI 48375

When Using This Product (When using this product)
  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water

Ask A Doctor Before Use If (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.

Stop Use and Ask A Doctor If (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
Keep Out of Reach of Children (Keep out of reach of children)

 If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in  pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • under a doctor’s care for any serious condition
  • taking any other drug


Advanced Ingredient Data


Raw Label Data

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