PRAMOXINE HYDROCHLORIDE aerosol, foam

Pramoxine hydrochloride by

Drug Labeling and Warnings

Pramoxine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Mayne Pharma, Sciarra Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PURPOSE

STOP USE

KEEP OUT OF REACH OF CHILDREN

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

PRAMOXINE HYDROCHLORIDE 
pramoxine hydrochloride aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51862-180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
YELLOW WAX (UNII: 2ZA36H0S2V)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETETH-20 (UNII: I835H2IHHX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
TROLAMINE (UNII: 9O3K93S3TK)
TETRAFLUOROMETHANE (UNII: 94WG9QG0JN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51862-180-15	1 in 1 CARTON	10/31/2011
1		15 g in 1 CONTAINER; 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	10/31/2011

Labeler - Mayne Pharma (867220261)

Establishment
Name	Address	ID/FEI	Business Operations
Sciarra Laboratories, Inc.		824900369	MANUFACTURE(51862-180) , PACK(51862-180) , LABEL(51862-180)