PREPARATION H FOR WOMEN- witch hazel cloth

PREPARATION H FOR WOMEN by

Drug Labeling and Warnings

PREPARATION H FOR WOMEN 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 20%

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

• open the lid on the top of the wipes pouch
• grab the top wipe at the edge of the center fold and pull out of pouch
• close lid after each use to retain moisture
• 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

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

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, diazolidinyl urea, dipropylene glycol, DMDM hydantoin, edetate disodium, fragrance, glycerin, methylisothiazolinone, methylparaben, PEG-75 shea butter glycerides, phenoxyethanol, polysorbate 20, propylene glycol, propylparaben, purified water, sodium citrate, vitamin E acetate

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 - 48 Wipe Pouch Carton

new!

PREPARATION H®
MEDICATED WIPES

for Women
HEMORRHOIDAL WIPES WITH WITCH HAZEL

infused with refreshing
CUCUMBER, SOOTHING ALOE,
VITAMIN E, SHEA BUTTER & CHAMOMILE

Works quickly to relieve burning & itching
Protects the irritated area for
effective hemorrhoid relief
Particularly useful in relieving discomfort
from hemorrhoids following childbirth

48
MEDICATED
WIPES

FLUSHABLE
6 x 5 in. (15.2 x 12.7 cm)

INGREDIENTS AND APPEARANCE

PREPARATION H FOR WOMEN 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-0559
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	2 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)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-0559-10	10 in 1 CARTON	04/01/2014
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0573-0559-40	1 in 1 CARTON	04/01/2014
2		48 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0573-0559-41	48 in 1 POUCH; Type 0: Not a Combination Product	04/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	04/01/2014

Labeler - Wyeth Consumer Healthcare LLC (828831730)