Label: PRAMOXINE HYDROCHLORIDE aerosol, foam
Contains inactivated NDC Code(s)
NDC Code(s): 54868-5865-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 68220-143
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 23, 2012
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Do not exceed the recommended daily dosage unless directed by a physician.
If condition worsens or does not improve within 7 days, consult a physician.
In case of rectal bleeding, consult a physician promptly.
Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum.
Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician.
- Place cap on container. Shake well before use.
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
- Gently dry by patting or blotting with toilet tissue or a soft cloth before application of proctofoam®.
- Dispense proctofoam® onto a clean tissue and apply externally to the affected area up to 5 times daily.
- Children under 12 years of age: consult a physician.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 g Carton
INGREDIENTS AND APPEARANCE
pramoxine hydrochloride aerosol, foam
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5865(NDC:68220-143) Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength pramoxine hydrochloride (UNII: 88AYB867L5) (pramoxine - UNII:068X84E056) pramoxine hydrochloride 150 mg in 15 g Inactive Ingredients Ingredient Name Strength cetyl alcohol (UNII: 936JST6JCN) glyceryl monostearate (UNII: 230OU9XXE4) methylparaben (UNII: A2I8C7HI9T) polyoxyl 40 stearate (UNII: 13A4J4NH9I) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) trolamine (UNII: 9O3K93S3TK) isobutane (UNII: BXR49TP611) propane (UNII: T75W9911L6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-5865-0 1 in 1 CARTON 1 15 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 02/22/2008 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel