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NDC 00573-0553-60 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES 200 mg/1 Details

PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES 200 mg/1

PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING 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	00573-0553
Product ID	0573-0553_0d7692dc-06b5-468a-9882-42d9f773bc33
Associated GPIs	90970035004300
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES
Proprietary Name Suffix	n/a
Non-Proprietary Name	witch hazel
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	200
Active Ingredient Units	mg/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 00573-0553-60 (00573055360)

Pricing Information	N/A
NDC Package Code	0573-0553-60
Billing NDC	00573055360
Package	60 CLOTH in 1 POUCH (0573-0553-60)
Marketing Start Date	2020-03-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 485437a8-b2e9-4acf-a20e-edb1f08a9cae Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

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: 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 wipe at a time
•: store at 20-25°C (68-77°F)

Inactive ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 60 Wipe Pouch Carton

180

WIPES

3 PACKS

PREPARATION H®

soothing

RELIEF

cleansing & cooling

wipes

HEMORRHOIDAL WIPES

with WITCH HAZEL

Cools on Contact

Gentle for Daily Use

With Aloe

Flushable

3 x 60

COUNT

POUCHES

6 x 5 in. (15.2 x 12.7 cm)

PRINCIPAL DISPLAY PANEL - 60 Wipe Pouch

NEW!

PREPARATION H®

soothing

RELIEF

cleansing & cooling

wipes

PEEL HERE

HEMORRHOIDAL WIPES

with WITCH HAZEL

Cools on Contact

Gentle for Daily Use

With Aloe

Flushable

60

WIPES

6 x 5 in. (15.2 x 12.7cm)

INGREDIENTS AND APPEARANCE

PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES

witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-0553
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0573-0553-95	3 in 1 CARTON	03/04/2020
1		60 in 1 POUCH; Type 0: Not a Combination Product
2	NDC:0573-0553-60	60 in 1 POUCH; Type 0: Not a Combination Product	03/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part346	03/04/2020

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

Revised: 3/2021

Document Id: 0d7692dc-06b5-468a-9882-42d9f773bc33

Set id: 485437a8-b2e9-4acf-a20e-edb1f08a9cae

Version: 2

Effective Time: 20210309