Aspercreme Arthritis

Aspercreme Arthritis
SPL v4
SPL
SPL Set ID 762b7ef4-166c-43b8-9acd-2b9e7fa0bf36
Route
TOPICAL
Published
Effective Date 2025-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diclofenac (0.01 g)
Inactive Ingredients
Carbomer Homopolymer Type C Cocoyl Caprylocaprate Isopropyl Alcohol Mineral Oil Polyoxyl 20 Cetostearyl Ether Propylene Glycol Water Ammonia

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-04-15 Until 2024-10-04

Description

ASPERCREME ARTHRIT I S PAIN Drug Facts

Purpose

Arthritis pain reliever *nonsteroidal anti-inflammatory drug


Medication Information

Purpose

Arthritis pain reliever

*nonsteroidal anti-inflammatory drug

Description

ASPERCREME ARTHRIT I S PAIN Drug Facts

Use

 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. 

Section 42229-5

ASPERCREME ARTHRIT I S PAIN

Drug Facts

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.

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 Aspercreme Arthritis Pain. 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

Questions?

Call 1-866-844-2798 or visit www. a spercreme.com

Keep carton as it contains important information .

Active Ingredient

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

Other Information

 store at 20-25°C (68-77°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

Principal Display Panel

A spercreme

ARTHRITIS PAIN


NET WT 3.53 OZ (100g)

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 age 18 years. It is not known if this drug works or is safe in children under age 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 or side of body

     slurred speech

If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out of Reach of Children.

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

Ask A Doctor Or Pharmacist Before Use If You Are

 under a doctor’s care for any serious condition

 taking any other drug


Structured Label Content

Use

 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. 

Section 42229-5 (42229-5)

ASPERCREME ARTHRIT I S PAIN

Drug Facts

Purpose

Arthritis pain reliever

*nonsteroidal anti-inflammatory drug

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.

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 Aspercreme Arthritis Pain. 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

Questions?

Call 1-866-844-2798 or visit www. a spercreme.com

Keep carton as it contains important information .

Active Ingredient (Active ingredient)

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

Other Information (Other information)

 store at 20-25°C (68-77°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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

A spercreme

ARTHRITIS PAIN


NET WT 3.53 OZ (100g)

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 age 18 years. It is not known if this drug works or is safe in children under age 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 or side of body

     slurred speech

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

ask a health professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

 under a doctor’s care for any serious condition

 taking any other drug


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