PRAMOXINE HYDROCHLORIDE aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

Mayne Pharma

INN (International Name):

PRAMOXINE HYDROCHLORIDE

Composition:

PRAMOXINE HYDROCHLORIDE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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.

Authorization status:

OTC monograph final

Summary of Product characteristics

PRAMOXINE HYDROCHLORIDE - PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM
MAYNE PHARMA
_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._
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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.