Flushable Hemorrhoidal Medical Wipes: Package Insert and Label Information

FLUSHABLE HEMORRHOIDAL MEDICAL WIPES- witch hazel patch
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Witch Hazel 50%

Purpose

Hemorrhoidal Astringent

Uses

Temporarily relieves these external symptoms associated with hemorrhoids:

• itching
• burning
• irritation

Warnings

For external 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, Aloe Barbadensis Leaf Extract, Sodium Citrate, Citric Acid, Glycerin, Phenoxyethanol, Potassium Sorbate

Flush only one wipe at a time. Keep lid tightly closed when not in use.

Gently pull out wipe to dispense

Safe for well-maintained sewers and septic systems

Not recommended for use with basement pump systems

Principal Display Panel

NDC 30142-314-48

COMPARE TO the active ingredient of PREPARATION H^® MEDICATED WIPES

*See back panel

Kroger^®

MAXIMUM STRENGTH

Flushable Hemorrhoidal Medicated Wipes

Witch Hazel, 50%

Gentle Everyday Cleansing to Reduce Irritation

With Aloe

PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

48 MEDICATED WIPES 6.0 IN x 5.0 IN (15.2 cm x 12.7 cm)

NDC 30142-314-96

COMPARE TO the active ingredient of PREPARATION H^® MEDICATED WIPES

*See bottom panel

Kroger^®

MAXIMUM STRENGTH

Flushable Hemorrhoidal Medicated Wipes

Witch Hazel, 50%

Gentle Everyday Cleansing to Reduce Irritation

With Aloe

PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

2 X 48 CT PACKS

96 MEDICATED WIPES

FLUSHABLE HEMORRHOIDAL MEDICAL WIPES witch hazel patch

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-314 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 500 mg in 1000 mg

Inactive Ingredients Ingredient Name Strength WATER ALOE VERA LEAF SODIUM CITRATE CITRIC ACID MONOHYDRATE GLYCERIN PHENOXYETHANOL POTASSIUM SORBATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:30142-314-48 48 PATCH in 1 BOX contains a PATCH 1 500 mg in 1 PATCH This package is contained within the BOX (30142-314-48) 2 NDC:30142-314-96 96 PATCH in 1 BOX contains a PATCH 2 500 mg in 1 PATCH This package is contained within the BOX (30142-314-96)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/31/2020

Labeler — Kroger Company (006999528)

Revised: 03/2020 Kroger Company