FDA Label for Diclolidol Kit

Diclofenac Sodium 1% Topical Gel

Active ingredient: Diclofenac sodium (NSAID*) 1%

*nonsteroidal anti‑inflammatory drug

Inactive Ingredients:

Carbomer Homopolymer Type C, Coco-Caprylate/caprate, Isopropyl Alcohol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, Strong Ammonia Solution

Purpose:

Arthritis pain reliever

Indications:

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.

For the temporary relief of pain.

Directions:

These highlights do not include all the information needed to use Diclofenac Sodium 1% Topical Gel safely and effectively.

See full prescribing information for Diclofenac Sodium 1% Topical Gel.

Initial U.S. Approval: 1988

• 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 for your arthritis pain:

• Use 4 times per day every day
• Do not use on more than 2 body areas at the same time

Per dose 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 Guidefor 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: See Full Prescribing Information For Diclofenac Sodium

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.

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

Ask A Doctor Or Pharmacist Before Use If You Are:

• 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 or side of body
• slurred speech

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 right away.

Other Information:

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

Description: Lidotral® 5% Roll On Gel

Lidotral® 5% Roll on Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Cyclopentasiloxane, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-21.

Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:

Clinical Pharmacology:

Mechanism of Action: Lidotral® 5% Roll on Gel releases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting local anesthetic action. A mild acidic vehicle lowers pH to increase protection against alkaline irritants and to provide a favorable environment for healing.

Pharmacokinetics:

Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration and total dosage. In general, the rate of absorption of local anesthetic agents following topical application occurs most rapidly after intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract, but little intact drug appears in the circulation because of biotransformation in the liver.

Lidocaine is metabolized rapidly by the liver and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/ toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The plasma binding of lidocaine is dependent on drug concentration and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 g of free base per mL, 60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Studies of lidocaine metabolism following intravenous bolus injections have shown that the elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics, but may increase the accumulation of metabolites. Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6 g free base per mL. In the rhesus monkey, arterial blood levels of 18-21 g/mL have been shown to be threshold for convulsive activity.

Warnings:

For external use only. Not for ophthalmic use.

PRECAUTIONS:

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidotral® 5% Roll on Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.

Use in Pregnancy: Teratogenic Effects; Pregnancy Category B. Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

Pediatric Use: Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

Contraindications:

Tuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Adverse Reactions:

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.

Dosage:

Adults and children 12 years of age and older: apply a thin film to the affected areas(s) two or three times per day or as directed by a licensed healthcare practitioner.

How Supplied:

Lidotral® 5% Roll on Gel is supplied in a 3 oz. (85 g) roll on bottle (NDC 59088-327-07).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at 20°-25°C (68°-77° F) [see USP Controlled Room Temperature]. Protect from freezing.

Diclolidol Kit Lidotral 5% Roll On Gel 3Oz And Diclofenac Sodium 1% Gel 100G

Manufactured by:

PureTek Corporation

Panorama City, CA 91402

For questions or information call toll-free: 877-921-7873