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

Preparation H Rapid Relief by

Drug Labeling and Warnings

Preparation H Rapid Relief by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, PF Consumer Healthcare Canada ULC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Glycerin 14.4%	Protectant
Lidocaine 5%	Local anesthetic
Phenylephrine HCl 0.25%	Vasoconstrictor
White petrolatum 15%	Protectant

INDICATIONS & USAGE

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

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 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 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

STORAGE AND HANDLING

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 23 g Tube Label

To open: push down on cap while turning counterclockwise.

Child-Resistant Cap

PREPARATION H®

HEMORRHOIDAL CREAM

RAPID RELIEF
WITH LIDOCAINE

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

NET WT 0.75 OZ (23g)

PRINCIPAL DISPLAY PANEL - 23 g Tube Carton

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g
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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	11/01/2018

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
PF Consumer Healthcare Canada ULC		203812479	ANALYSIS(0573-2843) , LABEL(0573-2843) , MANUFACTURE(0573-2843) , PACK(0573-2843)