FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
For external use only. Not for ophthalmic use. Product could harm small children if chewed or swallowed. Individual tubes are NOT child resistant.
Keep product and cleansing wipes out of the reach of children.
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
ZyPram™ is used for anti-inflammatory and anesthetic relief of itching, pain 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
ZyPram™ Cream is a topical preparation containing hydrocortisone acetate 2.35% in a cream base and pramoxine hydrochloride 1% in a hydrophilic cream base1. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-dihydroxy-(11β)-. It has the following structural formula:
Pramoxine hydrochloride has chemical name 4-[3-(4-butoxyphenoxy) propyl]morpholine hydrochloride, and has the following structure:
Active ingredients: Hydrocortisone Acetate 2.35% and Pramoxine Hydrochloride 1%.
Inactive ingredients: Ammonium Acryloyldimethyltaurate/VP-Copolymer, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Olivate (&) Sorbitan Olivate, PEG-12 Glyceryl Distearate=GDS-12, PEG-12 Glyceryl Dimyristate=GDM-12, Glycerine, Glyceryl Stearate, Methyl Paraben, PEG 100 Stearate, Polysorbate 60, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, White Petrolatum.
Cleansing Wipe (2.2 grams solution per wipe) Contains:
Citric Acid . . . . . . . . . . . . . . . . . . . . . . . 22 mg
Aloe Vera . . . . . . . . . . . . . . . . . . . . . . . 11 mg
Vitamin E (dl-tocopheryl acetate) . . . . . . 2.2 mg
Inactive Ingredients: Water, Polysorbate 20, Phenoxyethanol, Methyl Paraben, Ethyl Paraben, Propyl Paraben, Butyl Paraben, Isobutyl Paraben, Extract Blend, Fragrance/Perfume.
- 1
- This unique Lipid base delivery system provides more of the active ingredients, and out-performs traditional (active) ingredient applications.
Sources
Zypram Manufacturers
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Vertical Pharmaceuticals, Inc
Zypram | Vertical Pharmaceuticals, Inc
Apply ZyPram™ cream to the affected area(s) three times daily or as directed by a physician. ZyPram™ 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 ZyPram™, or should worsen, discontinue use and seek the advice of your physician. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted
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