FDA Label for Clearacylic
View Indications, Usage & Precautions
Clearacylic Product Label
The following document was submitted to the FDA by the labeler of this product Lacer Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Salicylic Acid 5.7%
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 5.7% 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 5.7% 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.”]
Other
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.
Manufactured for:
Lacer Pharma, LLC
Biloxi, MS 39532
1-888-403-8874
Inactive Ingredient
In a vehicle composed of hydroxypropyl cellulose and propylene glycol.
Package Label.Principal Display Panel
ClearAcylic
5.7% Gel
FOR TOPICAL USE
NOT FOR OPHTHALMIC USE
NDC 73159-005-60
Net Weight: 60 g
Tube label
Carton Label
* Please review the disclaimer below.
