| 1 An Introduction to Sklice ® (ivermectin) Lotion, 0.5% SANOFI PASTEUR. Discovery Drive. Swiftwater, Pennsylvania 18370. US.IVE.12.08.004©

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An Introduction to Sklice® (ivermectin)Lotion, 0.5%

SANOFI PASTEUR. Discovery Drive. Swiftwater, Pennsylvania 18370. www.sanofipasteur.usUS.IVE.12.08.004 © 2012 Sanofi Pasteur Inc.

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Sklice Lotion Indication1

Approval ● Approved by the US Food and Drug Administration in February 2012

Indication● Sklice Lotion is a pediculicide indicated for the topical treatment of head lice

infestations in patients 6 months of age and older

Adjunctive Measures● Sklice Lotion should be used in the context of an overall lice management program:

● Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding, and towels

● Wash personal care items such as combs, brushes, and hair clips in hot water

● A fine tooth comb or special nit comb may be used to remove dead lice and nits

Important Safety Information● The most common adverse reactions (incidence <1%) were conjunctivitis, ocular

hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation

Please See Accompanying Full Prescribing Information for Sklice Lotion.Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.

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Highlights of Sklice Lotion’s Safety Profile Include:

● No Contraindications

● Adverse Reactions for Sklice Lotion● In pivotal trials less than 1% of patients experienced adverse events which

included conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation

●Warnings and Precautions for Sklice Lotion● In order to prevent accidental ingestion, Sklice Lotion should only be

administered on pediatric patients under the direct supervision of an adult

Please See Accompanying Full Prescribing Information for Sklice Lotion.

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Proven Effective in Clinical Trials

● In 2 clinical trials, patients received a single 10-minute treatment and were instructed not to nit comb1,a

● 14 days after a single treatment, no live lice were observed in 76.1% (54/71) and 71.4% (50/70) of patients1

● The most common adverse reactions (incidence <1%) were conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation

a Two randomized, double-blind, vehicle-controlled trials in patients 6 months of age and older with head lice infestations. The primary efficacy was assessed as the proportion of patients who were free of live lice at day 2 and through day 8 to the final evaluation 14 (+2) days following a single application.2


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Sklice Lotion Formulation

Formulation

● Each gram of Sklice Lotion contains 5mg of ivermectin

● Inactive ingredients include water, olive oil, oleyl alcohol, Crodalan AWS, lanolin alcohol, cyclomethicone, shea butter, sodium citrate, sorbitan tristearate, methylparaben, propylparaben, and citric acid

Mechanism of Action

● Binds selectively, with high affinity primarily to glutamate-gated chloride channels in invertebrate nerve, muscle cells1-3

● Increased permeability of cell membrane to chloride ions leads to:

● Hyperpolarization of nerve or muscle cell, resulting in paralysis and death ofthe parasite1

Please See Accompanying Full Prescribing Information for Sklice Lotion.Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012. 2. Cully DF, et al. J Biol Chem. 1996;271(33):20187-20191. 3. Kane NS, et al. Proc Natl Acad Sci. 2000;97(25):13949-13954.

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Product Application

● Topical use only, not for oral, ophthalmic, or intravaginal use1

● Apply product directly to dry hair, enough to thoroughly coat scalp and hair (up to 1 tube)1

● Leave the product on for 10 minutes and then rinse out with water1

● A 4-ounce tube is intended for single use; discard unused portion1

● Avoid contact with eyes1


Sklice Lotion should be used in the context of an overall lice management program.

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Sklice Lotion should be used in the context of an overall lice management program.

1 Apply Sklice Lotion directly to dry hair and scalp.Completely cover scalp and hair closest to the scalp first, then apply outwards toward the ends of hair. Avoid contact with eyes.

2 Rub Sklice Lotion throughout the hair.It is important to completely cover the entire head so that all lice and eggs are exposed to the lotion.

3 Be sure that each hair is coated from the scalp to the tip; use up to 1 entire tube (4 oz) to completely cover hair and scalp.

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Sklice Lotion: Instructions for Use1

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3


Important Safety Information for Sklice LotionThe most common adverse reactions (incidence <1%) were conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation

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4 Allow Sklice Lotion to stay on the hair and scalp for 10 minutes after it has been applied. Use a timer or clock. Start timing after you have completely covered the hair and scalp.

5 After 10 minutes, rinse lotion from hair and scalp using only water.

6 You or anyone who helps you apply Sklice Lotion should wash their hands after application.

7 Do not use Sklice Lotion again without talking to your health-care provider first.

Sklice Lotion: Instructions for Use (cont)1

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For single use only; do not re-treat. Discard tube after use.


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Summary

● Sklice Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older

● Sklice Lotion should be used in the context of an overall lice management program

● Single 10-minute treatment (single 4oz tube)

● Efficacy results in clinical trials ● 76% and 71% of patients were lice-free 14 days post-treatment in 2 pivotal phase 3 trials

● No nit combing required● A fine tooth comb or special nit comb may be used to remove dead lice and nits

Important Safety Information for Sklice Lotion● The most common adverse reactions (incidence <1%) were conjunctivitis, ocular

hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation

Please See Accompanying Full Prescribing Information for Sklice Lotion.

Documents

| 1 An Introduction to Sklice ® (ivermectin) Lotion, 0.5% SANOFI PASTEUR. Discovery Drive. Swiftwater, Pennsylvania 18370. US.IVE.12.08.004©