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Pramoxine hydrochloride by Mayne Pharma

Medically reviewed on November 29, 2017

Dosage form: aerosol, foam
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: Mayne Pharma
NDC Code: 51862-180

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.

Pramoxine Hydrochloride 1%

ACTIVE INGREDIENT:

Pramoxine hydrochloride 1%.

INACTIVE INGREDIENTS:

Cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene C12-C14 ether, PPG5 Ceteth-20, propylene glycol, propylparaben, purified water, sorbitan trioleate, trolamine, and inert propellant: tetrafluoroethane.

INDICATION:

Use for the temporary relief of pain and itching associated with hemorrhoids.

DIRECTIONS: SHAKE WELL BEFORE USE.

Dispense Pramoxine Hydrochloride 1% onto a clean tissue or pad and apply externally to the affected area up to 5 times daily. See carton for additional directions for use.

WARNINGS:

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. Certain persons can develop allergic reactions to 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 immediately and consult a physician. Do not use in the eyes or nose. Do not apply to large areas of the body.

CAUTION: FOR EXTERNAL USE ONLY.

Do not insert any part of the aerosol container into the rectum. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 49°C (120°F).

STORE UPRIGHT AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F). DO NOT REFRIGERATE.

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Distributed by:
Mayne Pharma
Greenville, NC 27834

Net Wt. 0.53 oz (15 g)

HOLD UPRIGHT TO DISPENSE

PRINCIPAL DISPLAY PANEL - 15 g Container Carton

NDC 51862-180-15

Pramoxine
Hydrochloride 1%

For external use only
Hemorrhoidal Foam-Non Steroid

SHAKE WELL BEFORE USING

Net Wt. 0.53 oz. (15 g)

Foam

maynepharma

PRAMOXINE HYDROCHLORIDE 
pramoxine hydrochloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51862-180
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
YELLOW WAX 
METHYLPARABEN 
CETETH-20 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITAN TRIOLEATE 
TROLAMINE 
TETRAFLUOROMETHANE 
Packaging
#Item CodePackage Description
1NDC:51862-180-151 CONTAINER in 1 CARTON
115 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34610/31/2011
Labeler - Mayne Pharma (867220261)
Establishment
NameAddressID/FEIOperations
Sciarra Laboratories, Inc.824900369MANUFACTURE(51862-180), PACK(51862-180), LABEL(51862-180)

 
Mayne Pharma

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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