ClearAcylic Pro 6.3% Gel For Topical Use Not for Opthalmic Use

ClearAcylic Pro by

Drug Labeling and Warnings

ClearAcylic Pro by is a Prescription medication manufactured, distributed, or labeled by Lacer Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEARACYLIC PRO- salycilic acid gel 
Lacer Pharma, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ClearAcylic Pro
6.3% Gel
For Topical Use
Not for Opthalmic Use

Active Ingredient

Salicylic Acid 6.3%

Indication

For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns or calluses.

Directions

Apply ClearAcylic Pro 6.3% Gel thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated (soaked in water) for at least five minutes prior to application. The medication is washed off in the morning. In those areas where occlusion is difficult or impossible, application may be made more frequently. Once clearing is apparent, the occasional use of ClearAcylic Pro 6.3% Gel will usually maintain the remission, unless hands are being treated, hands should be rinsed thoroughly after application.

Warnings

For external use only. Avoid contact with eyes and other mucous membranes. May cause mild irritation. If excess irritation or sensitivity occurs, discontinue use and consult your physician. Do not use on children under 2 years of age. Read Package insert carefully. Flammable. Keep away from heat and open flame. Keep this and all medications out of reach of children.

Storage and Handling

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP “Controlled Room Temperature.”]

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.
NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequivalency.

See package insert for more details.

Inactive Ingredient

In a vehicle composed of hydroxypropyl cellulose and propylene glycol.

Manufactured for:

Lacer Pharma, LLC

Biloxi, MS 39532

1-888-403-8874

ClearAcylic Pro

6.3% Gel

FOR TOPICAL USE

NOT FOR OPHTHALMIC USE

NDC: 73159-007-60

Net Weight: 60 g

Rx Only

Tube label

Carton Label

CLEARACYLIC PRO 
salycilic acid gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 73159-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	6.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73159-007-60	60 g in 1 TUBE; Type 0: Not a Combination Product	08/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/18/2024	10/13/2024

Labeler - Lacer Pharma, LLC (117072266)

Revised: 10/2024

Document Id: 2465dfd6-eabe-848d-e063-6294a90a7400

34391-3

Set id: 158778b5-4fcd-48c6-9564-6ed0d0e7b500

Version: 3

Effective Time: 20241013