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:

Trifecta Pharmaceuticals USA LLC

INN (International Name):

MINERAL OIL

Composition:

MINERAL OIL 14 g in 100 g

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 profects 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 profects 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 20°-25°C (68°-77°F)
Close cap tightly after use
Questions? Call 1-888-296-9067
INACTIVE INGREDIENTS
Beeswax, Benzoic