Gencare-arthritis Pain Relief

Gencare-arthritis Pain Relief
SPL v2
SPL
SPL Set ID 4b1438bb-8591-4237-abcb-91491f34ad8f
Route
TOPICAL
Published
Effective Date 2024-09-03
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 2024-09-10

Description

Drug Facts

Purpose

Arthritis pain reliever 


Medication Information

Purpose

Arthritis pain reliever 

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 51945-4

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 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

Questions?

Call + 1 (732) 994-2808 or email [email protected]

Active Ingredient

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

*nonsteroidal anti-inflammatory drug

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, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

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 or side of body

slurred speech

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.

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.

Keep Out of Reach of Children.

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

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

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.

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

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.

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%. 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 (732) 994-2808 or email [email protected]

Active Ingredient (Active ingredient)

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

*nonsteroidal anti-inflammatory drug

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, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

When Using This Product (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 or side of body

slurred speech

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.

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.

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 .

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)