ACTIVE INGREDIENTS:

MENTHOL 5.00%
CAPSAICIN 0.05%

PURPOSES:

TOPICAL ANALGESIC
TOPICAL ANALGESIC

USES:

FOR TEMPORARY RELIEF OF ACHES AND PAINS OF THE MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHES, STRAINS, BRUISES AND SPRAINS.

WARNINGS:

FOR EXTERNAL USE ONLY.

DIRECTIONS:

ADULTS AND CHILDREN 16 YEARS AND OVER: APPLY DIRECTLY TO AFFECTED AREA OF PAIN; CHANGE PATCH 1 TO 2 TIMES DAILY, OR AS DIRECTED BY A DOCTOR · CHILDREN UNDER 16 YEARS; ASK A DOCTOR BEFORE USING

HOW TO APPLY:
- CLEAN AND DRY AFFECTED AREA - TEAR OPEN POUCH AND REMOVE ONE PATCH
- REMOVE PROTECTIVE FILM AND APPLY DIRECTLY TO AFFECTED AREA OF PAIN
- RESEAL POUCH CONTAINING UNUSED PATCHES AFTER EACH USE
- WASH HANDS WITH SOAP AND WATER AFTER APPLYING

OTHER INGREDIENTS:

AQUA (DEIONIZED WATER), ALOE BARBADENSIS (ALOE VERA GEL) JUICE, DIAZOLIDINYL UREA, GLYCERIN, IODOPROPYNYL BUTYLCARBAMATE, METYL PARABEN, POLYSORBATE-80, PROPYL PARABEN, SODIUM POLYACRYLATE, TETRASODIUM EDTA.

Questions

DISTRIBUTED BY:
A.P.I. SOLUTIONS
DAPHNE, AL 36526
FOR QUESTIONS OR COMMENTS PLEASE CALL 855-878-1489

Package Insert

DESCRIPTION

Solaice (Menthol 5%/Capsaicin 0.05%) is a topical analgesic patch comprised of an adhesive material containing menthol and capsaicin that is applied to the skin. The size of the patch is approximately 3.3in x 4.9in.

Menthol is chemically designated as 2-Isopropyl-5- methylcyclohexanol. It is colorless, hexagonal crystals, usually needle-like; fused masses or crystalline powder with a pleasant, peppermint-like odor. If has a melting point between 31°C to 36° C.

Capsaicin is chemically designated as (6E)-N-(4-Hydroxy-3- methoxybenzyl)-8-methyl-6-nonenamide. It is a crystalline white powder. It has a melting point of 65° C.

Each adhesive patch contains 750 mg of menthol and 7.5mg of capsaicin. It also contains the following inactive ingredients: aqua (Deionized Water), aloe barbadensis (Aloe Vera Gel) diazolidinyl urea, glycerin, Iodopropynyl butylcarbamate, methyl paraben, polysorbate-80, propyl paraben, sodium polyacrylate, tetrasodium EDTA.

CLINICAL PHARMACOLOGY

Menthol works by targeting the k-opiod receptor on the TRPM8 neuron. The TRPM8 neuron is normallyactivated at temperatures between (8° - 28° C). Menthol causes the neuron to fire at temperatures above normal activation which triggers the characteristic cooling sensation. Also because of menthol's specific targeting of the k-opiod receptor, it is endowed with analgesic properties. Capsaicin is a naturally occurring compound. It is found in chili peppers and is what gives is "heat". Capsaicin has been found to be effective in reducing inflammation and pain. When capsaicin enters the body it binds with the protein TRPV1 which is located on pain and heat neurons. When the TRPV1 proton is activated (between 37° - 45° C) it opens the calcium ion channel and give the sensation of pain and heat. When capsaicin binds to the TRPV1 proton it forces the ion channel to open below its normal activation temperature which is why it gives the distinct heating sensation. It is thought that prolonged activation of these neurons by capsaicin depletes substance P, a neurotransmitter for pain and heat. the end result appears that the nerves are overwhelmed by the influx and unable to report pain for an extended period of time.

INDICATIONS AND USAGE

Solaice is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscles soreness and stiffness.

CONTRAINDICATIONS

Solaice is contraindicated in patients with a known history of sensitivity to any component of the product, including dietary intolerance of foods containing capsaicin.

WARNINGS

External Use Only
Solaice is intended only for topical application. Solaice may be harmful if chewed, swallowed, or otherwise ingested, or if used other than as directed. If you have taken Solaice by mouth contact 1 -800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Eye, Mucous Membrane, and Sensitive Skin Exposure
Solaice should not come into direct or indirect contact with eyes, mucous membranes, genitals, or other sensitive areas. If eyes or mucous membranes comes into direct or indirect contact with Solaice, flush with cool water. If skin not intended to be treated comes into direct or indirect contact with Solaice, wash the affected area with soap and cool water. (See PRECAUTIONS – Allergic Reaction)

Heat-Induced Chemical Burns
Areas treated with Solaice should not be exposed to heat or direct sunlight due to findings in studies of other products containing menthol and capsaicin (similar to Solaice) indicating the potential for serious skin injuries ranging from first- to third-degree chemical burns. Solaice should not be used for 1 hour before or after bathing, showering, swimming, sunbathing, using a hot tub, steam bath, sauna, or heating pad, or other heat or sunlight exposure to the treated area. Stop using Solaice and seek immediate medical attention if serious skin injury occurs from using Solaice in combination with heat.

Aerosolization of Capsaicin and Menthol
Aerosolization of capsaicin and menthol can occur on rapid removal of Solaice patches, particularly in patients and bystanders with a previously unknown sensitivity to these ingredients, possibly resulting in airway irritation (usually coughing and/or sneezing), or other reaction. If irritation of eyes, mucous membranes, or airways occurs without physical contact with Solaice immediately remove the affected individual from the vicinity of Solaice, and flush eyes and mucous membranes with cool water. Seek medical attention if symptoms worsen or persist. (See also PRECAUTIONS – Allergic Reaction)

Accidental Exposure in Children
The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Solaice patch, although the risk with this formulation has not been quantified. It is important for patients to store and dispose of Solaice out of the reach of children, pets and others. (See HANDLING AND DISPOSAL)

Excessive Dosing
Excessive dosing by applying Solaice to larger than recommended areas, or for longer than the recommended time, could result in increased absorption and higher blood concentrations. Longer duration of application, application of more than the recommended number of patches, smaller patients (especially children), or impaired elimination may all contribute to increasing the blood concentration.

PRECAUTIONS

General
Allergic Reactions
Patients allergic to menthol or capsaicin or any other ingredient in Solaice should not use Solaice.

Seek immediate medical attention if any affected individual experiences any sign or symptom of a serious allergic reaction, including:
• swelling, itchiness, or numbness of the eyes, face, tongue, mouth, or throat;
• chest tightness, wheezing, stridor (high-pitched breath sound), loud breathing, trouble breathing, or hoarseness of voice;
• confusion, sweating, nausea, or vomiting;
• widespread rash or severe hives; or
• lightheadedness, collapse, or unconsciousness.

Information for Patients
Non-Intact Skin
Solaice should be applied only to intact skin. Application to open wounds or to broken, damaged, or irritated skin may cause or exacerbate irritation and discomfort, although the degree has not been tested in Solaice, and may also result in higher blood concentrations from increased absorption.

Exposure to Eyes and Mucous Membranes
Direct or indirect contact of Solaice with eyes and mucous membranes should be avoided due to findings of severe irritation in animal studies of other products containing capsaicin. If eye or mucous membrane contact occurs, immediately flush the affected area(s) with cool water. If discomfort persists, seek medical attention. (See WARNINGS - Eye, Mucous Membrane, and Sensitive Skin Exposure)

Contact Lenses
Do not handle contact lenses for 1 hour after handling, applying, or removing Solaice. (See WARNINGS - Eye, Mucous Membrane, and Sensitive Skin Exposure)

Heat and Sunlight
Treated area should not be exposed to heat or direct sunlight due to the risk of serious skin injury, including chemical burns ranging , or serious skin . Solaice should not be used for 1 hour before or after bathing, showering, swimming, sunbathing, using a hot tub, steam bath, sauna, or heating pad, or other heat or sunlight exposure to the treated area. Stop using Solaice and seek immediate medical attention if serious skin injury occurs from using Solaice in combination with heat.

Compression and Bandages
Solaice should not be used in combination with any bandage, wrap, brace, stocking, therapeutic sock, or similar device or garment that compresses the affected area.

Pregnancy, Labor and Delivery, and Nursing Mothers
Solaice has not been studied in pregnant or nursing mothers or in the context of labor and delivery. Pregnant or nursing mothers should consult with a doctor before using Solaice.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Pediatric patients (children under 16 years of age) should not use Solaice without a doctor’s supervision and instruction.

ADVERSE REACTIONS

Solaice can cause temporary skin irritation and/or slight discomfort (a burning or stinging sensation) at the application site. If these effects become bothersome, remove the Solaice patch, wash the affected with soap and water, and do not reapply until the effects subside. Consult with a doctor if these effects worsen, recur, or persist for more than a few days.

If serious discomfort, or swelling or skin blistering, occurs, stop using Solaice immediately and seek medical attention.

Seek immediate medical attention if any affected individual experiences any sign or symptom of a serious allergic reaction, including:
• swelling, itchiness, or numbness of the eyes, face, tongue, mouth, or throat;
• chest tightness, wheezing, stridor (high-pitched breath sound), loud breathing, trouble breathing, or hoarseness of voice;
• confusion, sweating, nausea, or vomiting;
• widespread rash or severe hives; or
• lightheadedness, collapse, or unconsciousness.

DRUG ABUSE AND DEPENDENCE
Solaice does not contain any controlled substance and is not known to pose any significant risk of abuse or dependence.

OVERDOSAGE
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Solaice may be harmful if swallowed.

DOSAGE AND ADMINISTRATION

Apply Solaice to intact skin to cover the most painful part of the affected area, or as directed by a doctor. Apply up to four patches per day. Each patch should not be applied for more than 8 hours in a given 24-hour period. Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination.

When Solaice is used concomitantly with other products containing same or similar agents, the amount absorbed from all formulations must be considered.

HANDLING AND DISPOSAL

Wash hands with soap and water immediately after applying, removing, or handling Solaice, avoiding eye contact with Solaice. Do not store patch outside the sealed envelope. Apply immediately after removal from the protective envelope. Roll or fold used patches so that the adhesive side sticks to itself, and safely discard used patches where children and pets cannot get to them. Solaice (used and unused patches) should be kept out of reach of children.

HOW SUPPLIED
Solaice (Menthol 5%/Capsaicin 0.05% patch) is available as the following:

Box of 15 patches, packaged into 3 child-resistant, re-sealable, silver-colored envelopes (5 patches/envelope)

NDC 46144-146-01

Store below 25°C (77° F); excursion permitted to 15°-30°C (59°-86° F). [See USP Controlled Room Temperature].

Manufactured for:
A.P.I. Solutions, Inc.
7998 B American Way
Daphne, AL 36526

October 2014

Principal Display Panel

RX ONLY
SOLAICE PATCH
TOPICAL ANALGESIC - MENTHOL 5%/ CAPSAICIN 0.05%

LOT:
EXP:
NDC: 46144-146-01