HEMORRHOIDAL HYGIENE PADS- witch hazel solution 
Geritrex, LLC

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.

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Hemrrhoidal Hygiene pads

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

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

• 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.

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

If swallowed, contact the Poison Control Center immediately.

Label

HEMORRHOIDAL HYGIENE PADS 
witch hazel solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-004
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-004-2545 mL in 1 JAR; Type 0: Not a Combination Product07/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/31/2015
Labeler - Geritrex, LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex, LLC112796248manufacture(54162-004)

Revised: 12/2018
Document Id: b08efcdb-c3c8-4d01-9622-c078af808bc5
Set id: e04a9fbf-69c0-469e-9d07-30711c3d6bf6
Version: 4
Effective Time: 20181224
 
Geritrex, LLC