FAMILY WELLNESS MEDICATED COOLING PADS- witch hazel solution

FAMILY WELLNESS MEDICATED COOLING PADS by

Drug Labeling and Warnings

FAMILY WELLNESS MEDICATED COOLING PADS by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR. 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

DOSAGE & ADMINISTRATION

DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD, MATTHEWS, NC 28105 USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS MEDICATED COOLING PADS  
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-032
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
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: 55319-032-10	100 in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	09/30/2012

Labeler - FAMILY DOLLAR (024472631)