Preparation H by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC Drug Facts

Preparation H by

Drug Labeling and Warnings

Preparation H 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]

PREPARATION H  SOOTHING RELIEF COOLING- witch hazel aerosol, spray 
Haleon US Holdings LLC

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Drug Facts

Active ingredients

Witch hazel 20%

Purpose

Astringent

Uses

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporary relief of irritation and burning
• aids in protecting irritated anorectal areas

Warnings

For external use only

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.
• 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

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 pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying the spray.
• apply externally to the affected area up to 6 times daily or after each bowel movement
• children under 12 years of age: consult a doctor
• shake well before using
• hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, dehydroxanthan gum, edetate disodium, glycerin, isobutane, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

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 sleeve band around cap is broken or missing

Dist. By: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks owned or licensed by GSK

©2021 GSK or licensor

PAA172637 (Front Carton)

PRINCIPAL DISPLAY PANEL

NDC: 0573-2889-01

PREPARATION H

NEW!

soothing
RELIEF
cooling spray

HEMORRHOIDAL SPRAY

with ALOE

Quickly Soothes and Cools Discomfort

Relieves Itching, Burning and Irritation

Gentle for Daily Use

NET WT 2.7 OZ (77 g)

PREPARATION H   SOOTHING RELIEF COOLING
witch hazel aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2889
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOBUTANE (UNII: BXR49TP611)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2889-01	77 g in 1 CANISTER; Type 0: Not a Combination Product	04/12/2021	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	04/12/2021	05/01/2024

Labeler - Haleon US Holdings LLC (079944263)

Revised: 5/2025

Document Id: 3417cff4-f8e5-327e-e063-6394a90ad70a

34390-5

Set id: 35b4e678-b9e7-4fca-a99d-8f9f77e66e12

Version: 5

Effective Time: 20250501