Goodsense Medicated Pads (Witch Hazel) Solution [Geiss, Destin And Dunn, Inc.] -

GOODSENSE MEDICATED PADS (WITCH HAZEL) SOLUTION [GEISS, DESTIN AND DUNN, INC.]
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NDC	75981-007-47
Set ID	afa3ed3f-42e9-4839-8bb8-a5c2b4c9b1f1
Category	HUMAN OTC DRUG LABEL
Packager	GEISS, DESTIN AND DUNN, INC.
Generic Name
Product Class
Product Number
Application Number	PART346

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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

GOODSENSE MEDICATED PADS
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75981-007
Route of Administration	TOPICAL, RECTAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:75981-007-47	100 in 1 JAR
1		2.5 mL in 1 APPLICATOR

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

Labeler - GEISS, DESTIN AND DUNN, INC. (076059836)

Registrant - UNITED EXCHANGE CORP. (840130579)

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

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