HEMORRHOIDAL HYGIENE PADS- witch hazel solution

Hemorrhoidal Hygiene pads by

Drug Labeling and Warnings

Hemorrhoidal Hygiene pads by is a Otc medication manufactured, distributed, or labeled by Geritrex, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Witch Hazel 50%
Purpose: Hemorrhoidal Astringent

Uses

For temporary relief of local discomfort,
burning and irritation associated with Hemorrhoids

Directions

When practical, clean the affected area
with mild soap and warm water, and rinse
thoroughly
Gently dry by patting or blotting with
toilet tissue or a soft cloth before applying
Apply externally to the affected area up to
6 times daily or after each bowel movement
After application, discard pad
Children under 12 years of age: consult a
doctor

DOSAGE & ADMINISTRATION

Apply externally to the affected area up to
6 times daily or after each bowel movement

WARNINGS

For External Use Only
Avoid contact with the eyes
Consult a doctor
If condition worsens or does not improve within 7 days
In case of bleeding
Before exceeding the recommended dosage
DO NOT put this product into the rectum
using fingers or any mechanical device.

Other Ingredient

Alcohol, Citric Acid,
Deionized Water, DMDM Hydantoin,
Glycerin, Sodium Citrate.

STORAGE AND HANDLING

Store at room temperature 15°-30°C
(59°-86°F)

KEEP OUT OF REACH OF CHILDREN

If swallowed, contact the Poison Control Center immediately.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL HYGIENE PADS 
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-004
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-004-25	45 mL in 1 JAR; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/31/2015

Labeler - Geritrex, LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex, LLC		112796248	manufacture(54162-004)