HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trifecta Pharmaceuticals Usa 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
TRIFECTA PHARMACEUTICALS USA 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
_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_
Adults and children 12 years of age and older for topical use:
Clean the affected area and pat or dab dry before applying ointment
Apply to the affected area up to 4 times daily, especially after bowel
movement
Attach included applicator to tube
Lubricate applicator tip and gently insert into rectum
Thoroughly clean applicator after each use and replace cover
Children under 12 years of age: ask a doctor before use
_OTHER INFORMATION_
Store at room temperature 20º-25ºC (68º-77ºF)
Close cap tightly after use
Questions? Call 1-888-296-9067
_INACTIVE I