PREPARATION H TOTABLES IRRITATION RELIEF WIPES- witch hazel cloth

PREPARATION H TOTABLES IRRITATION RELIEF WIPES by

Drug Labeling and Warnings

PREPARATION H TOTABLES IRRITATION RELIEF WIPES 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

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Witch hazel 50.0%

PURPOSE

Purpose

Astringent

INDICATIONS & USAGE

Uses

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

WARNINGS

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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 - 1 Wipe Packet

PREPARATION H®

MEDICATED
HEMORRHOIDAL
WIPES

WITH WITCH HAZEL

MAXIMUM STRENGTH FORMULA

WITH
ALOE

Tōtables®

Irritation Relief

1 INDIVIDUALLY WRAPPED FLUSHABLE WIPE
5.375 x 6.25 in. (13.6 x 15.8 cm)

PRINCIPAL DISPLAY PANEL - 10 Wipe Packet Carton

PREPARATION H®

MEDICATED
HEMORRHOIDAL
WIPES

WITH WITCH HAZEL

MAXIMUM STRENGTH FORMULA

WITH
ALOE

Tōtables®

Irritation Relief

10 INDIVIDUALLY WRAPPED FLUSHABLE WIPES
5.375 x 6.25 in. (13.6 x 15.8 cm)

INGREDIENTS AND APPEARANCE

PREPARATION H TOTABLES IRRITATION RELIEF WIPES 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0558
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 (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0558-07	10 in 1 CARTON	11/21/2010
1		1 in 1 PACKET; 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	11/21/2010

Labeler - Wyeth Consumer Healthcare LLC (828831730)