VA Class:DE700
ATC Class:D04AB07
Pramoxine preparations are used for self-medication for the temporary relief of pain and itching associated with minor lip or skin irritations (e.g., dermatoses, insect bites, minor burns or sunburns, minor cuts or scrapes, cold sores, rashes due to poison ivy, poison oak, or poison sumac).100, 102, 103, 108, 109, 110
Pramoxine preparations also are used for self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort associated with hemorrhoids or other anorectal/anogenital disorders (e.g., inflammation, irritation, fissures, anogenital pruritus).101, 104, 105, 106, 107, 111
Preparations containing pramoxine hydrochloride are applied topically.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111 These preparations may be applied to the lip in the form of an ointment (“lip balm”);108, 109 to the skin in the form of a gel, lotion, ointment, or solution;100, 102, 103, 110 to the external vaginal area in the form of pledgets (pads);111 or to the external anorectal area in the form of an aerosol foam, cream, ointment, or pledgets.101, 104, 105, 106, 107
The lotion containing pramoxine hydrochloride should be shaken well prior to use.102, 103, 107 The aerosol foam should be shaken well and dispersed onto a clean tissue before applying to the affected area.107 Pledgets should be applied gently by patting or wiping the affected area; pledgets should be used only once111 and then discarded.101, 111
Patients receiving pramoxine-containing preparations for the management of hemorrhoids or other anorectal disorders should be advised to cleanse the affected perianal area with mild soap and warm water and rinsing thoroughly whenever practical; the area then should be dried by patting or blotting with toilet tissue or a soft cloth before application of the drug.101, 104, 105, 106, 107
For self-medication for the temporary relief of pain and itching associated with lip or skin irritations in adults and children 2 years of age and older, pramoxine hydrochloride 1% gel, lotion, ointment, or solution is applied topically to the affected area up to 3 or 4 times daily.100, 102, 103, 108, 109, 110 For use in children younger than 2 years of age, a pediatrician should be consulted.100, 102, 103, 108, 109, 110
For self-medication for the temporary relief of pain, soreness, burning, itching, or discomfort caused by hemorrhoids or other anorectal disorders in adults and children 12 years of age and older, pramoxine hydrochloride 1% aerosol foam, cream, ointment, or pledget is applied topically to the affected area up to 4105 or 5 times daily101, 104, 106, 107 or after each bowel movement.101 The manufacturers state that this dosage should not be exceeded unless directed by a clinician.101, 104, 105, 107 For use in children younger than 12 years of age, a clinician should be consulted.101, 104, 105, 106, 107
For self-medication for the management of anogenital pruritus, pramoxine hydrochloride 1% pledget is applied to the external vaginal area up to 3-4 times daily.111 For use in children younger than 12 years of age, a clinician should be consulted.101, 104, 105, 106, 107
Local effects, such as burning or stinging, may occur following topical application of pramoxine. The drug has a low index of sensitization, and cross-sensitization with other local anesthetics is unlikely.
Precautions and Contraindications
Topical pramoxine preparations are for external use only.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111 Contact of pramoxine topical preparations with the eyes and nose should be avoided.100, 102, 103, 108, 109, 110, 111
Topical pramoxine preparations used for skin irritations should not be employed for vaginal, genital, or rectal itching.100 These preparations should not be applied to extensive areas of skin, open wounds, or damaged/blistered skin, and should not be used for prolonged periods.100, 102 Pramoxine-containing lip ointment should not be used on deep or puncture wounds, animal bites, or serious burns.108, 109
Topical pramoxine preparations used for hemorrhoids or other anorectal disorders should not be inserted into the rectum using fingers or any mechanical device.104, 105, 106, 107 The manufacturer of the aerosol foam preparation also warns against inserting any part of the aerosol container into the rectum.107 If rectal bleeding occurs during use of any of the topical pramoxine preparations, the drug should be discontinued and a clinician consulted.101, 104, 105, 106, 107
Allergic reactions to pramoxine or any ingredients in the formulation may develop in certain individuals.101, 106, 107 If an allergic reaction occurs, the drug should be discontinued and a clinician consulted.104, 105
If erythema, irritation, swelling, pain, or other symptoms develop or worsen during therapy, pramoxine should be discontinued and a clinician consulted.101, 102, 104, 105, 106, 107 Pramoxine also should be discontinued and a clinician consulted if pain and itching persist for more than 7 days, worsen, or resolve and occur again within a few days.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111
Preparations containing pramoxine hydrochloride should not be used to provide temporary relief of pain and itching associated with lip/skin irritations or hemorrhoids/anorectal disorders in children younger than 2 or 12 years of age, respectively, unless directed by a clinician.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111
Women who are pregnant should consult a clinician before initiating therapy with pramoxine-containing preparations.100, 105, 106
Women who are breast-feeding should consult a clinician before initiating therapy with pramoxine-containing preparations.100, 105, 106
Pramoxine is a local anesthetic that is structurally similar to dyclonine and does not contain the usual ester or amide linkage of the procaine-type drugs. Preparations of pramoxine are commercially available as the hydrochloride salt. Pramoxine hydrochloride occurs as a white to practically white, crystalline powder and may have a slight aromatic odor. The drug is freely soluble in water and in alcohol.
Pramoxine hydrochloride cream or ointment preprations should be stored in tight containers at a temperature of 15-30°C.100, 103, 104, 105 Pramoxine hydrochloride aerosol preparations, however, should be stored at room temperatures of 20-25°C, but may be exposed to temperatures ranging from 15-30°C.107 Commercially available aerosol preparations should not be refrigerated.107 Because the contents are under pressure, the aerosol container also should not be punctured, burned, or exposed to temperatures greater than 49°C.107
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Aerosol, foam suspension | 1%* | Pramoxine Hydrochloride Foam | |
Proctofoam® | Schwarz | |||
Cream | 1%* | Hemorrhoidal Anesthetic Cream | Clay-Park | |
Pramoxine Hydrochloride Topical Cream | ||||
Gel | 1% | Itch-X® | Ascher | |
PrameGel® | Doak | |||
Lotion | 1% | Prax® Lotion | Ferndale | |
Ointment | 1% | Campho-Phenique® Cold Sore Treatment for Scab Relief | Bayer | |
Pledgets (saturated with solution) | 1% | Fleet® Pain-Relief Pads | Fleet | |
Vagisil® Anti-itch Medicated Wipes | Combe | |||
Solution | 1% | Itch-X® Spray | Ascher |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Cream | 1% with Phenylephrine Hydrochloride 0.25% | Hemorid® Creme® | McNeil |
Lotion | 1% with Calamine 8% | Caladryl® Lotion | McNeil | |
Ointment | 1% with Allantoin 1.5% | Neosporin LT® Lip Treatment | Blistex | |
1% with Dimethicone 2% | Blistex Pro Relief® | Blistex | ||
1% with Phenylephrine Hydrochloride 0.25% | Hemorid® | McNeil | ||
1% with Zinc Oxide 12.5% | Tucks® Hemorrhoidal | McNeil |
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions January 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
100. B.F. Ascher & Co., Inc. Itch-X® gel/spray product information. Lenexa, KS; undated.
101. Fleet. Fleet® pain-relief pads product information. From the drugstore.com website ([Web]). Accessed 2005 Jan 6.
102. Ferndale Laboratories, Inc. Prax® lotion product information. Ferndale, MI; undated.
103. Pfizer consumer healthcare. Caladryl® clear lotion product information. In: Physicians' desk reference. From the Drugs.com website ([Web]). Accessed 2005 Jan 6.
104. Pfizer consumer healthcare. Anusol® hemorrhoidal ointment product information. Morris Plains, NJ; undated.
105. Pfizer consumer healthcare. Hemorid® hemorrhoidal ointment product information. Morris Plains, NJ; 2001.
106. Monticello Companies, Inc. Tronolane® hemorrhoidal cream product information. Jacksonville, FL; undated.
107. Schwarz Pharma. Proctofoam® non-steroidal hemorrhoidal foam product information. Milwaukee, WI; undated.
108. Blistex Inc. Blistex Pro Relief® lip balm product information. Oak Brook, IL; undated.
109. Pfizer consumer healthcare. Neosporin LT® lip treatment product information. Morris Plains, NJ; undated.
110. Bayer consumer care. Campho-Phenique® cold sore treatment with scab relief product information. Morristown, NJ; undated.
111. Combe Inc. Vagisil® anti-itch medicated wipes product information. White Plains, NY; undated.