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NDC 00573-0556-07 PREPARATION H MEDICATED WIPES 5 g/1 Details

PREPARATION H MEDICATED WIPES 5 g/1

PREPARATION H MEDICATED WIPES is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is WITCH HAZEL.

Product Information

NDC	00573-0556
Product ID	0573-0556_01a3b602-0d23-4230-b264-20bed3efc369
Associated GPIs	90970035004300
GCN Sequence Number	066102
GCN Sequence Number Description	witch hazel MED. PAD 50 % TOPICAL
HIC3	Q3D
HIC3 Description	HEMORRHOIDAL PREPARATIONS
GCN	28286
HICL Sequence Number	021836
HICL Sequence Number Description	WITCH HAZEL
Brand/Generic	Generic
Proprietary Name	PREPARATION H MEDICATED WIPES
Proprietary Name Suffix	n/a
Non-Proprietary Name	witch hazel
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	g/1
Substance Name	WITCH HAZEL
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00573-0556-07 (00573055607)

Pricing Information	N/A
NDC Package Code	0573-0556-07
Billing NDC	00573055607
Package	10 PACKET in 1 CARTON (0573-0556-07) / 1 CLOTH in 1 PACKET
Marketing Start Date	2004-02-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8d9961f0-1ecf-d7fb-b6b4-856d636d68e1 Details

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

•: open the lid on the top of the wipes pouch
•: peel back wipes seal, remove completely and discard
•: 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

OTHER INFORMATION

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

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

PREPARATION H Medicated Wipes

Hemorrhoidal Wipes with Witch Hazel

MAXIMUM STRENGTH FORMULA

Gentle, Everyday Cleansing To Reduce Irritation

48 Medicated Wipes With Aloe

Cools, Soothes and Comforts

Convenient, Easy to Use

For Hemorrhoidal and Vaginal Care

Flushable and Septic Safe

6 x 5 in. (15.2 x 12.7 cm)

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

Marketed By Wyeth Consumer Healthcare

Madison, NJ 07940 USA

10 Wipes Individually Wrapped

Each wipe is enclosed in a sealed foil pouch. Do not use if the pouch is broken or torn.

Other Uses

•: for vaginal care – cleanse the area by gently wiping, patting or blotting. Repeat as needed.
•: for use as a moist compress – if necessary, first cleanse the area as previously described. Fold new wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

INGREDIENTS AND APPEARANCE

PREPARATION H MEDICATED WIPES

witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-0556
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0573-0556-07	10 in 1 CARTON	02/02/2004
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC:0573-0556-96	2 in 1 CARTON	02/02/2004
2	NDC:0573-0556-20	48 in 1 POUCH; Type 0: Not a Combination Product
3	NDC:0573-0556-20	48 in 1 POUCH; Type 0: Not a Combination Product	02/02/2004

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	02/02/2004

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2022

Document Id: 01a3b602-0d23-4230-b264-20bed3efc369

Set id: 8d9961f0-1ecf-d7fb-b6b4-856d636d68e1

Version: 7

Effective Time: 20220107