MEDICATED WIPES- witch hazel patch

medicated wipes by

Drug Labeling and Warnings

medicated wipes by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution Inc., U. S. Nonwovens Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Witch Hazel 50%

Purpose

Hemorrhoidal Astringent

Uses

Temporarily relieves these external symptoms associated with hemorrhoids:

• itching
• burning
• irritation

Warnings

For external rectal use only.

When using this product

• do not exceed the recommended daily dosage unless directed by a doctor.
• do not insert into rectum or vagina using fingers or mechanical device.

Stop use and ask a doctor if

• rectal 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 at 1-800-222-1222.

Directions

As hemorrhoidal treatment for adults:

• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
• gently dry by patting or blotting with toilet tissue or soft cloth before applying.
• gently apply to the affected area by patting and then discard.
• can be used up to six times daily or after each bowel movement.

Children under 12 years of age

• consult a doctor.

Other Information

Store at controlled room temperature: 15º-30ºC (59º-86ºF)

Inactive Ingredients

Water, Sodium citrate, Citric acid, Glycerin, Phenoxyethanol, Potassium sorbate

Principal Display Panel

NDC: 41250-988-48

meijer

Compare to Preparation H® active ingredient*

medicated wipes

Hemorrhoidal Wipes with Witch Hazel

MAXIMUM STRENGTH

Provides Temporary Relief of Itching, Burning and Irritation

6 IN x 48 WIPES 5 IN (15.2 cm x 12.7 cm)

NDC: 41250-988-96

meijer

Compare to Preparation H® active ingredient*

medicated wipes

Hemorrhoidal Wipes with Witch Hazel

MAXIMUM STRENGTH

Provides Temporary Relief of Itching, Burning and Irritation
For Use with Hemorrhoids and for Vaginal Care
Convenient, Easy to Use

96 WIPES (2 x 48 CT. PACKS)
6 IN x 5 IN (15.2 cm x 12.7 cm)

INGREDIENTS AND APPEARANCE

MEDICATED WIPES 
witch hazel patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-988
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	500 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-988-48	48 in 1 BOX	10/02/2019
1		500 mg in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 41250-988-96	96 in 1 BAG	10/02/2019
2		500 mg in 1 PATCH; 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	06/28/2018

Labeler - Meijer Distribution Inc. (006959555)

Registrant - Meijer Distribution Inc. (006959555)

Establishment
Name	Address	ID/FEI	Business Operations
U. S. Nonwovens Corp		080453184	manufacture(41250-988)