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Prescribing Information Highlights

Please see full Prescribing Information for complete details on product information.

Sklice Lotion Dosage and Administration¹

• For topical use only. Not for oral, ophthalmic or intravaginal use.
• Apply Sklice Lotion to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp.
• After 10 minutes, rinse off with water.
• The tube is intended for single use. Discard any unused portion.
• Avoid contact with eyes.

Sklice Lotion Dosage Forms and Strengths¹

Topical Lotion: 0.5%

Sklice Lotion Contraindications¹

None

Sklice Lotion Warnings and Precautions¹

Accidental ingestion in pediatric patients may occur. Administer only under direct adult supervision.

Most common adverse reactions (incidence <1%) are conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin burning sensation.

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc. at 1-800-835-3592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See Section 17 of the Prescribing Information for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

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 For Sklice Lotion:

In order to prevent accidental ingestion, Sklice Lotion should only be administered to pediatric patients under the direct supervision of an adult.

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

Before administering Sklice Lotion, please see the full Prescribing Information.

References

1. Sklice Lotion [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2012.