An Introduction to Sklice ivermectin Lotion 0 5

An Introduction to Sklice® (ivermectin) Lotion, 0. 5% SANOFI PASTEUR. Discovery Drive. Swiftwater, Pennsylvania 18370. www. sanofipasteur. us US. IVE. 12. 08. 004 © 2012 Sanofi Pasteur Inc. | 1

Sklice Lotion Indication 1 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. | 2

Highlights of Sklice Lotion’s Safety Profile Include: ● No Contraindications ● Adverse Reactions for Sklice Lotion ● Warnings and Precautions 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 ● 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. | 4

Proven Effective in Clinical Trials a ● In 2 clinical trials, patients received a single 10 -minute treatment and were instructed not to nit comb 1, a ● 14 days after a single treatment, no live lice were observed in 76. 1% (54/71) and 71. 4% (50/70) of patients 1 ● The most common adverse reactions (incidence <1%) were conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation 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 Please See Accompanying Full Prescribing Information for Sklice Lotion. Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. ; 2012. | 5

Sklice Lotion Formulation ● ● Each gram of Sklice Lotion contains 5 mg 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 cells 1 -3 ● Increased permeability of cell membrane to chloride ions leads to: ● Hyperpolarization of nerve or muscle cell, resulting in paralysis and death of the parasite 1 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. | 6

Product Application Sklice Lotion should be used in the context of an overall lice management program. ● Topical use only, not for oral, ophthalmic, or intravaginal use 1 ● 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 water 1 ● A 4 -ounce tube is intended for single use; discard unused portion 1 ● Avoid contact with eyes 1 Please See Accompanying Full Prescribing Information for Sklice Lotion. Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. ; 2012. | 7

Sklice Lotion: Instructions for Use 1 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. 1 2 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 3 Please See Accompanying Full Prescribing Information for Sklice Lotion. Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. ; 2012. | 8

Sklice Lotion: Instructions for Use (cont)1 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 6 After 10 minutes, rinse lotion from hair and scalp using only water. 7 Do not use Sklice Lotion again without talking to your health-care provider first. You or anyone who helps you apply Sklice Lotion should wash their hands after application. 4 For single use only; do not re-treat. Discard tube after use. 5 Please See Accompanying Full Prescribing Information for Sklice Lotion. Reference: 1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. ; 2012. | 9

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 4 oz tube) ● Efficacy results in clinical trials ● No nit combing required ● 76% and 71% of patients were lice-free 14 days post-treatment in 2 pivotal phase 3 trials ● 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. | 10