LEXETTE (Page 4 of 4)

INSTRUCTIONS FOR USELEXETTE® (lex-et) (halobetasol propionate) Topical Foam, 0.05%

Read the Patient Information and Instructions for Use before you use LEXETTE.

Important information: LEXETTE is for skin use only. Do not get LEXETTE in your mouth, eyes, or vagina.

Parts of the LEXETTE can:

Figure
(click image for full-size original)
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Step 1: Before applying LEXETTE for the first time, remove cap and break the small tab at the base of the actuator by gently pushing the actuator away from the tab as shown. Do not break the hinge on the actuator.

Figure
(click image for full-size original)

Step 2: Shake the can well before use.

Figure

Step 3: Turn the can completely upside down.

Figure

Step 4: Press down on the actuator to dispense a small amount of the foam into the palm of your hand.

Figure
(click image for full-size original)

Step 5: Apply a thin layer of LEXETTE to the affected skin area. Gently rub LEXETTE into the affected skin until the foam disappears. Repeat Steps 4 and 5 to all the affected areas as prescribed by your healthcare provider.

Figure
(click image for full-size original)

Step 6: After applying LEXETTE, put the cap back on the can. Step 7: Wash your hands after applying LEXETTE unless you are using the medicine to treat your hands.

Distributed by: Mayne Pharma
Raleigh, NC 27609
U.S. Patent 10,857,159 and 11,020,407
Revised: 03/2023

PRINCIPAL DISPLAY PANEL — 50 g Canister Carton

NDC 51862-604-50

LEXETTE™
(halobetasol propionate)
Topical Foam, 0.05%

For topical use only.

Rx ONLY

Net Wt. 50 g

24976 mayne pharma

PRINCIPAL DISPLAY PANEL -- 50 g Canister Carton
(click image for full-size original)
LEXETTE halobetasol propionate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-604
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Halobetasol propionate (Halobetasol) Halobetasol propionate 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
Propylene Glycol
POLAWAX POLYSORBATE
Polyoxyl 20 Cetostearyl Ether
Cetostearyl Alcohol
WATER
Benzoic Acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51862-604-50 1 CANISTER in 1 CARTON contains a CANISTER
1 50 g in 1 CANISTER This package is contained within the CARTON (51862-604-50)
2 NDC:51862-604-33 1 CANISTER in 1 CARTON contains a CANISTER
2 17 g in 1 CANISTER This package is contained within the CARTON (51862-604-33)
3 NDC:51862-604-02 2 CANISTER in 1 CARTON contains a CANISTER
3 50 g in 1 CANISTER This package is contained within the CARTON (51862-604-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210566 04/23/2019
Labeler — Mayne Pharma (867220261)
Establishment
Name Address ID/FEI Operations
Pharmasol Corporation 065144289 ANALYSIS (51862-604), MANUFACTURE (51862-604), PACK (51862-604), LABEL (51862-604)

Revised: 08/2023 Mayne Pharma

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