HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Pharmacy Value Alliance, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Vasoconstrictor Protectant Protectant - Helps relieve the local itching and discomfort associated with hemorrhoids - Temporarily shrinks hemorrhoidal tissue and relieves burning - Temporarily provides a coating for relief of anorectal discomforts - Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful - bleeding occurs - condition worsens or does not improve within 7 days - introduction of applicator into the rectum causes additional pain

Authorization status:

OTC monograph final

Summary of Product characteristics

HEMORRHOIDALOINTMENT- MINERAL OIL, PETROLATUM, PHENYLEPHRINE
HCI OINTMENT
PHARMACY VALUE ALLIANCE, LLC
_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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HEMORRHOIDAL OINTMENT
DRUG FACTS
ACTIVE INGREDIENT
Phenylephrine HCI 0.25%
PURPOSE
Vasoconstrictor
ACTIVE INGREDIENT
Mineral Oil 14%
PURPOSE
Protectant
ACTIVE INGREDIENT
Petrolatum 74.9%
PURPOSE
Protectant
USES
Helps relieve the local itching and discomfort associated with
hemorrhoids
Temporarily shrinks hemorrhoidal tissue and relieves burning
Temporarily provides a coating for relief of anorectal discomforts
Temporarily protects the inflamed, irritated anorectal surface to help
make bowel
movements less painful
WARNINGS
FOR EXTERNAL AND/OR ANORECTAL USE ONLY
ASK DOCTOR BEFORE USE IF YOU HAVE
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
ASK DOCTOR BEFORE USE IF YOU ARE presently 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
STOP USE AND ASK DOCTOR IF
bleeding occurs
condition worsens or does not improve within 7 days
introduction of applicator into the rectum causes additional pain
IF PREGNANT OR BREAST-FEEDING
Ask a doctor before use
KEEP OUT OF REACH OF CHILDREN
If swallowed get medical help or contact a Poison Control Center right
away.
DIRECTIONS
Children under 12 years of age: ask a doctor before use
Adults: when practical, clean the affected area by patting or blotting
with an appropriate
cleansing wipe
gently dry by patting or blotting with a tissue or soft cloth before
applying
when first opening tube, remove foil seal
for intrarectal use: remove protective cover from applicator into the
rectum
lubricate applicator well, then gently insert applicator into the
rectum
thoroughly clean applicator and replace prot