PREPARATION H COOLING GEL- phenylephrine hcl, witch hazel gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)

Available from:

Haleon US Holdings LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Vasoconstrictor Astringent - helps relieve the local itching and discomfort associated with hemorrhoids - temporary relief of irritation and burning - temporarily shrinks hemorrhoidal tissue - aids in protecting irritated anorectal areas

Authorization status:

OTC monograph final

Summary of Product characteristics

PREPARATION H COOLING GEL- PHENYLEPHRINE HCL, WITCH HAZEL GEL
HALEON US HOLDINGS LLC
----------
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Phenylephrine HCl 0.25%
Witch hazel 50.0%
_PURPOSES_
Vasoconstrictor
Astringent
_USES_
helps relieve the local itching and discomfort associated with
hemorrhoids
temporary relief of irritation and burning
temporarily shrinks hemorrhoidal tissue
aids in protecting irritated anorectal areas
_WARNINGS_
FOR EXTERNAL USE ONLY
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland
ASK A DOCTOR OR PHARMACIST 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
do not put this product into the rectum by using fingers or any
mechanical device or
applicator
STOP USE AND ASK A DOCTOR IF
bleeding occurs
condition worsens or does not improve within 7 days
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.
_DIRECTIONS_
adults: when practical, cleanse the affected area by patting or
blotting with an
appropriate cleansing wipe. Gently dry by patting or blotting with a
tissue or a soft
cloth before applying gel.
when first opening the tube, puncture foil seal with top end of cap
apply externally to the affected area up to 4 times daily, especially
at night, in the
morning or after each bowel movement
children under 12 years of age: ask a doctor
_OTHER INFORMATION_
store at 20-25°C (68-77°F)
_INACTIVE INGREDIENTS_
aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose,
methylparaben,
polysorbate 80, propylene glycol, propylparaben, purified water,
sodium citrate,
sulisobenzone, vitamin E acetate
_QUESTIONS OR COMMENTS?_
Call weekdays 9 AM to 5 PM EST at 1-800-99PREPHor 1-800-997-7374
ADDITIONAL INFORMATION
DO NOT USE IF T