NumbSkin® 5% Lidocaine Cream – 15 gram – (NDC 70907-001-15)

NumbSkin® 5% Lidocaine Cream - 15 gram - (NDC 70907-001-15)

For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area associated with anorectal disorders.

DRUG LABEL INFORMATION

NDC Code(s): 70907-001-15
Packager: Seenext Venture Ltd.

Category: HUMAN OTC DRUG

ACTIVE INGREDIENT

Lidocaine 5%

PURPOSE

Anorectal (Hemmorrhoidal)

WARNINGS

For external use only When using this product

Do not exceed the recommended daily dosage unless directed by a doctor
Do not put into the rectum by using fingers or any mechanical device or applicator

Stop the use and consult doctor if

Allergic reaction occurs
Rectal bleeding occurs
Redness, irritation, swelling, pain, or other symptoms begin or increase
Condition worseness or does not improve within 7 days

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

DIRECTIONS

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product
When first opening the tube, twist the cap and peel off the foil seal
Apply externally to the affected area up to 6 times daily
Children under 12 years of age: consult a doctor

OTHER INFORMATION

Always keep the tube tightly closed
Store at temperature not exceeding 59°F – 86°F (15°C – 30°C)
Protect from freezing

INACTIVE INGREDIENTS

Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water

OTHER PRODUCT INFORMATION

What is NumbSkin®? NumbSkin® is an innovative non-prescription topical anesthetic cream approved by FDA & Korea Food and Drug Administration (KFDA) to control pain associated with minor medical/aesthetic skin operation, laser, waxing, tattoo, anorectal disorders and skin irritations. It has an optimum strength of 5% pure lidocaine for an extended shelf-life up to three years. NumbSkin® formula is compliant to the provisioned standards of FDA and Korean Pharmacopoeia (KP) on quality, performance, and storage to ensure product efficacy and safety of consumers. What is NumbSkin® indicated for? 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 disorders.
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).

How is Numbskin® Administered? 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.

QUESTION OR COMMENTS

PRINCIPAL DISPLAY PANEL

NDC 70907-001-15

5% Lidocaine Cream

For External Use Only

NumbSkin Lidocaine Cream 15g