PREPARATION H RAPID RELIEF- glycerin, lidocaine, phenylephrine hydrochloride cloth

Preparation H Rapid Relief by

Drug Labeling and Warnings

Preparation H Rapid Relief by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

• 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

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.

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

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

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)

INGREDIENTS AND APPEARANCE

PREPARATION H RAPID RELIEF 
glycerin, lidocaine, phenylephrine hydrochloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0554
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0554-10	10 in 1 CARTON	03/01/2019
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 0573-0554-20	20 in 1 CARTON	03/01/2019
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0573-0554-30	30 in 1 CARTON	03/01/2019
3		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	03/01/2019

Labeler - Wyeth Consumer Healthcare LLC (828831730)