"Sage Products announced on July 29 that it is voluntarily recalling one lot of Comfort Shield Barrier Cream Cloths to the distributor and healthcare facility/user level because of product contamination with the bacterium Burkholderia"...
ULESFIA® Lotion is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
Limitation Of Use
ULESFIA® Lotion does not have ovocidal activity.
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.
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® Lotionper Application|
|Ounces||8 oz bottle Size|
|Short||0-2 inches||4-6 oz||½ to ¾ bottle|
|2-4 inches||6-8 oz||¾-1 bottle|
|Medium||4-8 inches||8-12 oz||1-1½ bottles|
|8-16 inches||12-24 oz||1½-3 bottles|
|Long||16-22 inches||24-32 oz||3-4 bottles|
|Over 22 inches||32-48 oz||4-6 bottles|
Dosage Forms And Strengths
ULESFIA® Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion).
Storage And Handling
ULESFIA® Lotion is a white topical lotion containing benzyl alcohol, 5% (50 mg/g of lotion)
NDC 59212-780-08 as an 8 fl oz (227 g) in a polypropylene
NDC 59212-780-88 as a package containing two individual 8 fl oz (NDC 59212-780-08) polypropylene bottles with a nit comb
Store at 20° C - 25° C (68° F - 77° F); excursions permitted to 15° C - 30° C (59° F - 86° F) [See USP controlled room temperature].
Do not freeze.
MANUFACTURED FOR: Concordia Pharmaceuticals Inc., Bridgetown, Barbados BB11128. BY: Contract Pharmaceuticals Limited, Mississauga, Ontario L5N 6L6, Canada. Revised: 09/2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/17/2016
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