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 Akron Pharma Inc.. 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

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

• If swallowed, get medical attention or contact the Poison Control Center immediately.

Directions:

• When practical, clean the affected area with mild soap and warm water, and rinse thoroughly

DOSAGE & ADMINISTRATION

• 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

Other Information

• Store at room temperature 15°-30°C (59°-86°F)
• If adverse effects call 1-877-225-6999

Other Ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL HYGIENE PADS 
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0110
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0110-1	175 mL in 1 JAR; Type 0: Not a Combination Product	10/25/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	10/25/2019

Labeler - Akron Pharma Inc. (067878881)

Registrant - Akron Pharma Inc. (067878881)

Establishment
Name	Address	ID/FEI	Business Operations
SLV PHARMACEUTICALS LLC		081225162	manufacture(71399-0110)