FAMILY CARE MEDICATED HEMORRHOIDAL- witch hazel cloth

FAMILY CARE MEDICATED HEMORRHOIDAL by

Drug Labeling and Warnings

FAMILY CARE MEDICATED HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by UNITED EXCHANGE CORPORATION, AMERICAN HYGIENICS CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                                         Purpose

Witch Hazel 50% .......................................................................................Astringent

PURPOSE

Uses

Temporarily relieves these external symptoms associated with hemorrhoids: itching, burning, irritation

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product

• do not exceed the recommended daily dosage unless directed by a doctor
• do not put directly in rectum by using fingers or any mechanical device
  

STOP USE

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• As hemorrhoidal treatment for adults:
• 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 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: ask a doctor.
  

STORAGE AND HANDLING

Other information: store at 59o to 77oF

INACTIVE INGREDIENT

Inactive ingredient:

water, glycerin, alcohol, propylene glycol, sodium citrate, diazolidinyl urea, citric acid, methylparaben, and propylparaben

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in China

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

FAMILY CARE MEDICATED HEMORRHOIDAL  
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-802-09	8 in 1 CARTON
1		1 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/20/2011

Labeler - UNITED EXCHANGE CORPORATION (840130579)

Registrant - UNITED EXCHANGE CORPORATION (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
AMERICAN HYGIENICS CORPORATION		545198454	manufacture