ULESFIA Lotion Ref.[9951] Active ingredients: Benzyl alcohol

Source: FDA, National Drug Code (US)  Revision Year: 2019 

1. Indications and Usage

1.1 Indication

ULESFIA Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

1.2 Limitation of Use

ULESFIA Lotion does not have ovocidal activity.

1.3 Adjunctive Measures

ULESFIA 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.

2. Dosage and Administration

ULESFIA Lotion is not for oral, ophthalmic, or intravaginal use.

Using the guidelines in Table 1, apply sufficient ULESFIA Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat application after 7 days. Avoid contact with eyes.

Table 1. ULESFIA Lotion Usage Guideline:

Hair Length Amount of ULESFIA Lotion per Application
Ounces8 oz bottle Size
Short 0-2 inches 4-6 oz ½-¾ bottle
2-4 inches 6-8 oz ¾-1 bottle
Medium 4-8 inches 8-12 oz 1-1½ bottles
8-16 inches12-24 oz 1½-3 bottles
Long 16-22 inches 24-32 oz 3-4 bottles
Over 22 inches 32-48 oz 4-6 bottles

10. Overdosage

If oral ingestion occurs, seek medical advice immediately.

16.2. Storage and Handling

Store at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF) [See USP controlled room temperature].

Do not freeze.

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