NIKZON HEMORRHOIDAL- phenylephrine hydrochloride and pramoxine hydrochloride cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

Genoma Lab USA Inc

INN (International Name):

PHENYLEPHRINE HYDROCHLORIDE

Composition:

PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- For the temporary relief of anorectal itching, burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles.

Authorization status:

OTC monograph final

Summary of Product characteristics

NIKZON HEMORRHOIDAL- PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE
HYDROCHLORIDE CREAM
GENOMA LAB USA 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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NIKZON
HEMORRHOIDAL CREAM
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Phenylephrine HCl 0.25%
Vasoconstrictor
Pramoxine HCl 1%
Local anesthetic
USES
For the temporary relief of anorectal itching, burning and discomfort
associated with
hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or
piles.
WARNINGS
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
high blood pressure
thyroid disease
diabetes
difficulty urinating due to enlarged prostate gland.
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking a prescription drug for high blood pressure or depression.
WHEN USING THIS PRODUCT
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.
STOP USE AND ASK A DOCTOR IF
rectal bleeding occurs
an allergic reaction occurs
the symptom being treated does not subside or if redness, irritation,
swelling, pain or
other symptoms develop or increase
condition worsens or does not improve within 7 days.
KEEP OUT OF REACH OF CHILDREN.
®
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Remove cap and lift foil safety seal from tube.
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 this product.
Apply externally to the affected area with a thin layer up to 4 times
daily.
Children under 12 years of age: consult a doctor.
OTHER INFORMATION
Store at room temperature 15-30°C (59-86°F)
Close cap tightly after use.
INACTIVE INGREDIENTS
Aloe Vera (Aloe Barbadensis) Extract, BHA, Carboxymet