FAMILY WELLNESS MEDICATED WIPES- witch hazel solution

FAMILY WELLNESS MEDICATED WIPES by

Drug Labeling and Warnings

FAMILY WELLNESS MEDICATED WIPES 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%...............................................................Anorectal/Astringent

PURPOSE

Uses

temporarily relieves the local itching and discomfort associated with hemorrhoids

aids in protecting irritated anorectal areas

temporarily relieves irritation and burning

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

• do not use more than directed unless told to do so by a doctor
• do not put directly in the rectum by using fingers or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• open the lid on top of the wipes pouch
• peel back wipes seal, remove completely and discard
• grab the top wipe at the edge of the center fold and pull out of pouch
• close lid after each use to retain moisture
• adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area
• use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard. Do Not Flush.
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

Store at room temperature 20-25°C (68-77°F)

protect from excessive heat

INACTIVE INGREDIENT

Inactive ingredients

alcohol, aloe vera leaf, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.

10401 MONROE RD.

MATTHEWS, NC 28105 USA

Made in China

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS MEDICATED WIPES 
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-031
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALCOHOL (UNII: 3K9958V90M)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-031-48	48 in 1 POUCH; Type 0: Not a Combination Product	09/30/2012

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)