PROCTOFOAM NS- 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:

Meda Pharmaceuticals

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

PROCTOFOAM NS- PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM
MEDA PHARMACEUTICALS
_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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DRUG FACTS
_ACTIVE INGREDIENT_
Pramoxine hydrochloride 1%
_PURPOSE_
Local anesthetic
_USE_
for the temporary relief of pain and itching associated with
hemorrhoids
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
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STOP USE AND ASK A DOCTOR IF
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IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
do not exceed the recommended daily dosage unless directed by a doctor
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
rectal bleeding occurs
condition worsens or does not improve within 7 days
allergic reaction occurs to the ingredients in this product
symptom being treated does not subside
redness, irritation, swelling, pain or other symptoms develop or
increase
_DIRECTIONS_
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_OTHER INFORMATION_
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_INACTIVE INGREDIENTS_
cetyl alcohol, glyceryl monostearate PEG-100 stearate blend,
isobutane, methylparaben,
polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane,
propylene glycol,
propylparaben, purified water, trolamine
_QUESTIONS?_
1-888-350-1908
Distributed by:
MEDA PHARMACEUTICALS INC.
Somerset, New Jersey 08873-4120
© 2021 Viatris Inc.
PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a
Viatris
Company..
PRINCIPAL DISPLAY PANEL – 1%
NDC 0037-6823-15
TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals
seal on ends of
carton are broken or missing.
PROCTOFOAM NON-STEROID
pramoxine hydrochloride 1%
hemorrhoidal foam
FOR TEMPORARY
place cap on container. Shake well before use
adults: when practica