Label: PROCTOFOAM NS- pramoxine hydrochloride aerosol, foam
- NDC Code(s): 0037-6823-15
- Packager: Meda Pharmaceuticals
- 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.
Drug Label Information
Updated July 27, 2018
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
When using this product
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- do not exceed the recommended daily dosage unless directed by a doctor
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- do not put this product into the rectum by using fingers or any mechanical device or applicator
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- do not insert any part of the aerosol container into the rectum
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Directions
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- place cap on container. Shake well before use
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- adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
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- gently dry by patting or blotting with toilet tissue or a soft cloth before application
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- dispense onto a clean tissue and apply externally to the affected area up to 5 times daily
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- children under 12 years of age: consult a physician
- Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
PROCTOFOAM NS
pramoxine hydrochloride aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0037-6823 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) PEG-100 STEARATE (UNII: YD01N1999R) METHYLPARABEN (UNII: A2I8C7HI9T) LAURETH-23 (UNII: N72LMW566G) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) ISOBUTANE (UNII: BXR49TP611) PROPANE (UNII: T75W9911L6) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0037-6823-15 1 in 1 CARTON 08/18/2014 1 15 g in 1 CANISTER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 08/18/2014 Labeler - Meda Pharmaceuticals (051229602)