Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Purposes

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Uses

for temporary relief of pain, soreness and burning
helps relieve the local itching and discomfort associated with hemorrhoids
temporarily shrinks 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

Ask a doctor or pharmacist before use if you arepresently 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 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.

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 this cream.
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 extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

PREPARATION H ®

New Benefit
Now Reduces Swelling
See new label

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL
CREAM

LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN
WHITE PETROLATUM

5%
HIGHEST STRENGTH
LIDOCAINE
AVAILABLE

Rapid numbing relief of pain,
itching & burning
Reduces swelling & provides
a soothing protective layer

1 TUBE | NET WT 0.75 OZ (23 g)

PREPARATION H RAPID RELIEF
glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-2843
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	150 mg in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
LAURETH-23 (UNII: N72LMW566G)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0573-2843-01	1 in 1 CARTON	11/01/2018
1		23 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0573-2843-10	1 in 1 CARTON	11/01/2018
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M015	11/01/2018

Labeler - Haleon US Holdings LLC (079944263)

Name	Address	ID/FEI	Business Operations
Establishment
Pf Soins De Sant? Sri		203812479	analysis(0573-2843) , label(0573-2843) , manufacture(0573-2843) , pack(0573-2843)

Drug Facts

Active Ingredients

Purposes

PRINCIPAL DISPLAY PANEL