Drug Facts

Composition & Product

Active Ingredients

Glycerin (200 mg) Lidocaine (50 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Aloe Vera Leaf Anhydrous Citric Acid Benzyl Alcohol Edetate Disodium Propylene Glycol Water Sodium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-03-01

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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

Dosage and 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

Description

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

Section 44425-7

Other information

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

Section 50565-1

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

Section 50568-5

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments?

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

Section 53414-9

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

Section 55105-1

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

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

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

Principal Display Panel 10 Wipe Pouch Carton

PREPARATION H ^®

New

RAPID RELIEF

WITH

LIDOCAINE

HEMORRHOIDAL WIPES

Totables _®

LIDOCAINE

PHENYLEPHRINE HCl

GLYCERIN

Hygienically-wrapped

for personal use

Quickly numbs away pain
Soothes burning & itching

on contact
Reduces swelling of

inflamed tissue

10

Individually Wrapped

FLUSHABLE WIPES

6 x 4 in. (15.2 x 10.2 cm)

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

When Using This Product (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 (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

Ask A Doctor Before Use If You Have (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

Principal Display Panel 10 Wipe Pouch Carton (PRINCIPAL DISPLAY PANEL - 10 Wipe Pouch Carton)

PREPARATION H ^®

New

RAPID RELIEF

WITH

LIDOCAINE

HEMORRHOIDAL WIPES

Totables _®

LIDOCAINE

PHENYLEPHRINE HCl

GLYCERIN

Hygienically-wrapped

for personal use

Quickly numbs away pain
Soothes burning & itching

on contact
Reduces swelling of

inflamed tissue

10

Individually Wrapped

FLUSHABLE WIPES

6 x 4 in. (15.2 x 10.2 cm)

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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", "34071-1": "Warnings For external use only", "44425-7": "Other information store at 20-25°C (68-77°F) for best results, flush only one at a time", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50568-5": "Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.", "51727-6": "Inactive ingredients aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, edetate disodium, propylene glycol, purified water, sodium benzoate", "53413-1": "Questions or comments? Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients Purposes Glycerin 20% Protectant Lidocaine 5% Local anesthetic Phenylephrine HCl 0.25% Vasoconstrictor", "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", "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", "PRINCIPAL DISPLAY PANEL - 10 Wipe Pouch Carton": "PREPARATION H ® New RAPID RELIEF WITH LIDOCAINE HEMORRHOIDAL WIPES Totables ® LIDOCAINE PHENYLEPHRINE HCl GLYCERIN Hygienically-wrapped for personal use Quickly numbs away pain Soothes burning & itching on contact Reduces swelling of inflamed tissue 10 Individually Wrapped FLUSHABLE WIPES 6 x 4 in. (15.2 x 10.2 cm)"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information