FDA Label for Preparation H Rapid Relief

View Indications, Usage & Precautions

OTHER
OTC - PURPOSE
INDICATIONS & USAGE
WARNINGS
ASK A DOCTOR BEFORE USE IF YOU HAVE
OTC - ASK DOCTOR/PHARMACIST
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
STORAGE AND HANDLING
INACTIVE INGREDIENT
OTC - QUESTIONS
PRINCIPAL DISPLAY PANEL - 1 WIPE POUCH LABEL
PRINCIPAL DISPLAY PANEL - 10 WIPE POUCH CARTON

Preparation H Rapid Relief Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Otc - Purpose

Active ingredients	Purposes
Glycerin 20%	Protectant
Lidocaine 5%	Local anesthetic
Phenylephrine HCl 0.25%	Vasoconstrictor

Indications & Usage

Uses

for temporary relief of pain, soreness and burning
helps relieve the local itching and discomfort associated with hemorrhoids
temporarily reduces the swelling associated with irritated hemorrhoidal tissue
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 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

Otc - Ask Doctor/Pharmacist

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

wash hands after use. Avoid contact with eyes
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
an allergic reaction develops
the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or soft cloth before applying wipe.
apply externally to affected area up to 4 times daily.
unfold wipe and gently apply to the affected area by patting and then discard.
children under 12 years of age: ask a doctor

Storage And Handling

Other information

store at 20-25°C (68-77°F)
for best results, flush only one at a time

Inactive Ingredient

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, edetate disodium, propylene glycol, purified water, sodium benzoate

Otc - Questions

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

Principal Display Panel - 1 Wipe Pouch Label

TO OPEN: FOLD BACK ON DOTTED LINE. TEAR ON ARROW OR USE SCISSORS

PREPARATION H^®

Child-Resistant Pouch

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL
WIPES

Totables_®

LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN

Quickly numbs away pain
Soothes burning & itching on contact
Reduces swelling of inflamed tissue

1 INDIVIDUALLY WRAPPED
FLUSHABLE WIPE

Not for
individual sale

6 x 4 in. (15.2 x 10.2 cm)

Principal Display Panel - 10 Wipe Pouch Carton