FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
WARNINGS: For external use only. Not for ophthalmic use. Product could harm small children if chewed or swallowed.
KEEP PRODUCT AND CLEANSING WIPES OUT OF THE REACH OF CHILDREN.
Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Ana-Lex™ should not be ingested or applied into the mouth, inside of the nose or in the eyes. Ana-Lex™ should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed in animals when instilled in the middle ear. Ana-Lex™ should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS: Ana-Lex™ is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: Each gram of Ana-Lex™ contains the active ingredients hydrocortisone acetate 20 mg and lidocaine hydrochloride 20 mg. Also contains a 1% (10 mg per gram) Coleus Forskohlii Base.* The inactive ingredients include aluminum sulfate, calcium acetate, carbomer, cetyl alcohol, citric acid, glycerine, methyl paraben, mineral oil, polycarophil, propyl paraben, propylene glycol, purified water, sodium citrate, sodium hydroxide, sodium lauryl sulfate, sorbitan stearate, stearic acid, stearyl alcohol, trolamine, urea and white petrolatum.
Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-(11ß)-. It has the following structural formula:
Lidocaine HCl is chemically designated as acetamide, 2(diethylamino)- N-(2,6-dimethylphenyl), and has the following structure:
Sources
Ana-lex Manufacturers
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Avion Pharmaceuticals, Llc
Ana-lex | Avion Pharmaceuticals, Llc
DOSAGE AND ADMINISTRATION: Remove the cleansing wipe from package and gently clean the affected area. Discard wipe after use. Please note that the cleansing wipe does not contain any active ingredients. Remove the child resistant cap and foil seal from the tube of Ana-Lex HC and screw on the provided applicator. Gently squeeze the tube until the applicator is full and a small amount of the cream comes out of the applicator opening. Insert the applicator tip gently into the anus and continue squeezing the body of the tube as it is moved around the areas of discomfort until the tube is empty. Do not completely insert the tube into the anus or insert deep into the rectum. Once the application is completed, the tube and applicator should be removed and discarded. Note that an adequate amount of Ana-Lex™ for an application to the anal and peri-anal area will be applied through the applicator tip by gently squeezing the tube during application. Ana-Lex™ should not be used in excess of recommendations or for prolonged use in the anal canal. If the condition does not respond to repeated courses of Ana-Lex™ or should worsen, discontinue use and seek the advice of your physician.
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