PREMIER VALUE MEDICATED PADS- witch hazel solution

PREMIER VALUE MEDICATED PADS by

Drug Labeling and Warnings

PREMIER VALUE MEDICATED PADS by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG CONSORTIUM, LLC, UNITED EXCHANGE CORP., 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, and irritation

WARNINGS

Warnings

For external use only.  Avoid contact with eyes.

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 20o to 25oC (68o to 77oF)

INACTIVE INGREDIENT

Inactive ingredients: alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

Other Uses

For vaginal care- cleanse the area by gently wiping, patting or blotting with pad and discard.  Repeat as needed.

DOSAGE & ADMINISTRATION

Distributed by:

Geiss, Destin and Dunn Inc.

Peachtree City, GA 30269

www.valuelabels.com

Made in China

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PREMIER VALUE MEDICATED PADS 
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-410
Route of Administration	RECTAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.5 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-410-91	100 in 1 JAR
1		2.5 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	06/01/2011

Labeler - CHAIN DRUG CONSORTIUM, LLC (101668460)

Registrant - UNITED EXCHANGE CORP. (840130579)

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