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:

Physicians Total Care, Inc.

INN (International Name):

pramoxine hydrochloride

Composition:

pramoxine hydrochloride 150 mg in 15 g

Administration route:

RECTAL

Prescription type:

OTC DRUG

Therapeutic indications:

Local Anesthetic for the temporary relief of pain and itching associated with hemorrhoids

Authorization status:

OTC monograph final

Summary of Product characteristics

PRAMOXINE HYDROCHLORIDE - PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM
PHYSICIANS TOTAL CARE, INC.
_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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PROCTOFOAM
NON-STEROID
(PRAMOXINE HYDROCHLORIDE 1%)
_DRUG FACTS_
ACTIVE INGREDIENT
Pramoxine hydrochloride 1%
PURPOS E
Local Anesthetic
US E
for the temporary relief of pain and itching associated with
hemorrhoids
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. 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.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
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.
®
®
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OTHER INFORMATION
Store upright at controlled room temperature 20° - 25°C (68° -
77°F); excursions permitted between
15° - 30°C (59° - 86°F).
Do not refrigerate.
Contents of the container are under pressure. Do not burn or puncture
the aerosol container.
Do not store at temperatures above 120°F (49°C).
INACTIVE INGREDIENTS
cetyl alcohol, gly