PREPARATION H RAPID RELIEF- lidocaine, phenylephrine hydrochloride spray

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Lidocaine 5%

Phenylephrine HCl 0.25%

Purposes

Local anesthetic

Vasoconstrictor

INDICATIONS & USAGE

Uses

• Helps relieve the local discomfort and itching associated with hemorrhoids
• For the temporary relief of pain, soreness or burning
• Temporarily reduces the swelling associated with irritation in hemorrhoids
• Temporarily shrinks hemorrhoidal tissue

WARNINGS

Warnings

For external use only

Flammable:Do not use while smoking or near heat or flame

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 this product into the rectum by using fingers or any mechanical device or applicator
• Warning -avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
• Warning -use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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 pad
• Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• Shake well before using
• Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
• Apply externally to the affected area up to 4 times daily
• Children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• Store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf juice, citric acid, disodium EDTA, glycerin, isobutane, malic acid, menthol, propyl gallate, propylene glycol, SD alcohol 40-B, sodium benzoate, water

QUESTIONS

Questions or comments?

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

Additional Information

No-Touch Spray

Do not use if clear safety seal around cap is broken or missing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

@2021 GSK or licensor

For most recent product information, visit www.preparationh.com

PRINCIPAL DISPLAY PANEL

NEW!

PREPARATIONH

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL SPRAY

LIDOCAINE
PHENYLEPHRINE HCl

• Rapid numbing relief of pain,

  itching and burning

• Reduces swelling of
  inflamed tissue
• Highest strength lidocaine

  available

NET WT 3.8 OZ (107.7 g)

000070918 Front Label

INGREDIENTS AND APPEARANCE

PREPARATION H RAPID RELIEF 
lidocaine, phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2890
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOBUTANE (UNII: BXR49TP611)
MALIC ACID (UNII: 817L1N4CKP)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2890-01	107.7 g in 1 CANISTER; Type 0: Not a Combination Product	02/01/2022
2	NDC: 0573-2890-02	127.6 g in 1 CANISTER; Type 0: Not a Combination Product	02/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	02/01/2022

Labeler - Haleon US Holdings LLC (079944263)