Curist Arthritis Relief (diclofenac Sodium Topical Gel 1%)

Curist Arthritis Relief (diclofenac Sodium Topical Gel 1%)
SPL v5
SPL
SPL Set ID e638a98e-e6d7-36ed-e053-2995a90af2ca
Route
TOPICAL
Published
Effective Date 2022-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diclofenac (1 g)
Inactive Ingredients
Carbomer Homopolymer Type C Coco-caprylate/caprate Isopropyl Alcohol Mineral Oil Polyoxyl 20 Cetostearyl Ether Propylene Glycol Water Ammonia

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-08-15

Description

Drug Facts


Medication Information

Warnings and Precautions

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 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.

Indications and 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 and 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% Arthritis Pain. The dosing card is re-usable.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • Store at 20-25 oC (68°F - 77°F). Keep from freezing.
  • read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 50567-7

When using this product

  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking any other drug
Section 50569-3

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.
Section 50570-1

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
Section 51727-6

Inactive ingredients

Carbomer homopolymer type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.

Section 51945-4

curist

Arthritis Relief

Diclofenac Sodium Topical Gel 1%

(NSAID)- Arthritis Pain Reliever

Original Prescription Strength

For Daily Treatment of Arthritis Pain

Anti-Inflammatory

Compare to the active ingredient in Voltaren® Arthritis Pain Gel**

For external use only

Net Wt 5.29 oz (150 g)

Section 53413-1

Questions or comments? 1-844-243-1241

Section 53414-9

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.

Section 55105-1

Purpose

Arthritis pain reliever

Section 55106-9

Active ingredient

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

*nonsteroidal anti-inflammatory drug


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

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% Arthritis Pain. The dosing card is re-usable.
Warnings and Precautions (34071-1)

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 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.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • Store at 20-25 oC (68°F - 77°F). Keep from freezing.
  • read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes, nose, or mouth
  • if eye contact occurs, rinse thoroughly with water
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking any other drug
Section 50569-3 (50569-3)

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.
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients

Carbomer homopolymer type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.

Section 51945-4 (51945-4)

curist

Arthritis Relief

Diclofenac Sodium Topical Gel 1%

(NSAID)- Arthritis Pain Reliever

Original Prescription Strength

For Daily Treatment of Arthritis Pain

Anti-Inflammatory

Compare to the active ingredient in Voltaren® Arthritis Pain Gel**

For external use only

Net Wt 5.29 oz (150 g)

Section 53413-1 (53413-1)

Questions or comments? 1-844-243-1241

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Arthritis pain reliever

Section 55106-9 (55106-9)

Active ingredient

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

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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