4 Tubes of Numbskin Cream (10.56)

Product Information

NumbSkin™ is an innovative non-prescription topical anesthetic cream approved by Korea Food and Drug Administration (KFDA) to control pain associated with minor medical/aesthetic procedures, needle injection and minor skin operation. It has the strongest lidocaine mix out of all our products and extended shelf-life up to three years. NumbSkin™ formula is compliant to the provisioned standards of Korean Pharmacopoeia (KP) on quality, performance, and storage to ensure product efficacy and safety of consumers.

Features and Benefits

The unique proprietary formula of NumbSkin™ is made distinct by these features:

• rapid dermal absorption rate

• fast-acting and longer lasting effect (numbs the skin within 15 minutes and lasts up to 4 hours)

• may be reapplied to maintain peak effect of anesthesia

• does not require occlusive wrap but using occlusion method over the applied cream enhances skin absorption and extended localized effect

• non-irritating, non-oily and water soluble

Indications

NumbSkin™ is indicated for (including but not limited to):

• temporary relief of pain and/or itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, perianal discomfort and anorectal disoders

• dermal procedures that induce pain such as venipuncture (blood sampling), intravenous cannulation (administration of contrast agents, fluids, medications, parenteral nutrition and blood products), minor skin procedures (laceration repair, warts removal), laser treatment procedures, hair removal (waxing and electrolysis), body art (tattoo and piercings), cosmetic procedures (microdermabrasion, microneedle therapy, injectable filler treatments)

Administration Route

The route of administration of NumbSkin™ is via topical application on the skin. Recommended dose for adults is 0.5 grams per one square inch of skin. NumbSkin™ should be applied no more than 30% of body surface area. To compute for percentage of coverage, refer to the illustrations below:

Coverage area

One tube of NumbSkin™ cream can cover 60 square inches (1 coat application). The cream may also be re-applied in same areas to extend anesthetic effect. The estimated coverage for one tube may be lessened depending on the complexity of skin procedure especially those that require more application.

Ingredients

NumbSkin™ contains the following:

Active Ingredient: Per 1g

Lidocaine (KP)

Additive (Preservative): Benzalkonium Chloride

Inactive Ingredients: Castor oil, Ethanol, Glyceryl monostearate, Isopropyl myristate, Methyl p-hydroxybenzoate, Stearyl alcohol, Polyoxyethylate 40 hydrogenated castor oil, Propylene glycol, Purified water

• KP stands for Korean Pharmacopoeia. The Korean Pharmacopoeia is a statute for pharmaceuticals established by Korean government for improvement of public health. KP is served as the characteristics of official standard for the description and quality of drugs which are generally recognized to be safe and efficacious in the treatment and prevention of diseases and its role should be to specify the standards of drugs in preparation, identification, efficacy, quality and storage.

Product Packaging

NumbSkin™ cream is contained in a pharmaceutical-grade laminated tube with barrier and preservation properties to keep the contents protected. The tube has a twist cap closure with puncture to pierce through the seal allowing the contents flow out seamlessly.

Mechanism of Action

Lidocaine works by temporarily blocking this pathway of pain signals along nerves. It does this by stopping the sodium entering the nerve ending at the site of the pain. This prevents an electrical signal building up and passing along the nerve fibres to the brain. Lidocaine may be absorbed following topical administration. The extent of anesthetic effect is dependent on its absorption rate, concentration and total dose administered, the specific site of application, and the duration of exposure.

NumbSkin™ Effects on Specific Populations

People with allergies. Allergic reaction on medicines belonging to the anesthetic group or any other medicines must be disclosed to the attending physician and other healthcare professionals involved. The effect could range from mild reactions to extremely life-threatening allergic responses such as difficulty of breathing and anaphylactic shock. For serious allergic reactions, call professional medical help immediately.

Pregnant women. Although studies on effects in pregnancy have not been done in humans, topical anesthetics have not been reported to cause problems in humans. Lidocaine has not been shown to cause birth defects or other problems in animal studies. Other topical anesthetics have not been studied in animals.

Nursing Mothers. Topical anesthetics have not been reported to cause problems for breastfeeding mothers nor babies. However, general precaution must be observed. Use NumbSkin™ under supervision of a physician.

Children. Lidocaine may be absorbed through the skin of young children and may cause unwanted effects if they have any allergies to anesthetics, medications and pre-existing medical conditions that can interfere with the mechanism of action of lidocaine. The skin of young children is thinner and less impervious to the passage of foreign substances thus, it is more susceptible to lidocaine toxicity. Dermal absorption can be a significant exposure route for some medications, and given that children’s body systems are underdeveloped they may suffer greater adverse effects from such exposure. Check with the doctor before using NumbSkin™ cream on a child younger than two (2) years of age.

Elderly. Topical anesthetics have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical anesthetics in the elderly with use in other age groups. However, an important consideration for geriatric patients is to check if they have existing medical conditions that involve the heart, kidneys and liver as it will affect the retention and excretion of lidocaine from the body.

Safety Information

1. Do not use NumbSkin™ if:

• allergic (hypersensitive) to lidocaine or any of the ingredients of NumbSkin™

• skin is inflamed, blistered, eczematous or ulcerated

• pregnant or lactating

2. Supervised care when using NumbSkin™ on:

• geriatric and pediatric patients

• patients with heart, liver and kidney conditions or on medications contraindicated to NumbSkin™ formula

3. General Caution

• Stop using NumbSkin™ and seek medical attention immediately in cases of severe allergic reactions such as hives, difficulty of breathing, dizziness, blurring of vision, choking, facial swelling, tightness in the chest, fainting, slow or irregular heartbeat

• Avoid prolonged usage without medical consent or supervision of a doctor

4. Application Caution

• External use only. Avoid contact with eyes or nose. If this happens, flush the eyes thoroughly with clean water. Do not consume in large amounts

Adverse Reactions

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

• Large swellings that look like hives on the skin or in the mouth or throat

• Blurred or double vision

• confusion

• convulsions (seizures)

• dizziness or lightheadedness

• increased sweating

• ringing or buzzing in the ears

• shivering or trembling

• slow or irregular heartbeat

• troubled breathing

• unusual anxiety, excitement, nervousness, or restlessness

• unusual paleness

• unusual tiredness or weakness

Shelf-life

The shelf-life of NumbSkin™ is three years.

Storage

KEEP OUT OF REACH OF CHILDREN. Recommended storage temperature is from 1⁰ to 30⁰ C (33.8⁰ to 86⁰ F). Keep away from direct heat, freezing temperatures, and sunlight. Always close the tube tightly when not in use.