PREPARATION H- cocoa butter, phenylephrine hydrochloride, and witch hazel kit

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]

SPL UNCLASSIFIED SECTION

Preparation H® Suppositories

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Cocoa butter 88.44%	Protectant
Phenylephrine HCl 0.25%	Vasoconstrictor

Uses

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily relieves burning and 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 rectal 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

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days

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 insertion of this product.
• detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
• children under 12 years of age: ask a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, methylparaben, propylparaben

Questions or comments?

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

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

SPL UNCLASSIFIED SECTION

Preparation H® Totables® Irritation Relief Wipes

Drug Facts

Active ingredient

Witch hazel 50.0%

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

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve within 7 days

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: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
• use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
• children under 12 years of age: consult a doctor

Other information

• store at 20-25°C (68-77°F)
• for best results, flush only one or two wipes at a time

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - Kit Carton

SAME AMOUNT
Smaller Package

PREPARATION H®
HEMORRHOIDAL
SUPPOSITORIES

Provides Relief from
MULTIPLE SYMPTOMS

• ✓ Reduces Internal Swelling,
  Soothes & Protects
• ✓ Prompt Soothing Relief
  from Painful Burning,
  Itching and Discomfort
• ✓ Also for Nighttime Relief

+ 4 FREE
WIPES INSIDE

12 SUPPOSITORIES

INGREDIENTS AND APPEARANCE

PREPARATION H 
cocoa butter, phenylephrine hydrochloride, and witch hazel kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2884

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2884-12	1 in 1 CARTON	07/01/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	12
Part 2	1 APPLICATOR	4

Part 1 of 2

PREPARATION H 
cocoa butter and phenylephrine hydrochloride suppository

Product Information
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	2211 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	YELLOW (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		12 in 1 BLISTER PACK; 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	07/01/2015

Part 2 of 2

PREPARATION H TOTABLES IRRITATION RELIEF WIPES 
witch hazel cloth

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	5 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color	WHITE (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 APPLICATOR; 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	07/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	07/01/2015

Labeler - Wyeth Consumer Healthcare LLC (828831730)