PRE-MOISTENED MEDICATED WIPESHEMORRHOIDAL WIPEHEMORRHOIDAL WIPEHEMORRHOIDAL WIPEHEMORRHOIDAL WIPE HEMORRHOIDAL WIPES WITH WITCH HAZEL- witch hazel cloth

Pre-moistened Medicated WipesHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipe by

Drug Labeling and Warnings

Pre-moistened Medicated WipesHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipeHemorrhoidal wipe by is a Otc medication manufactured, distributed, or labeled by ARMY AND AIR FORCE EXCHANGE SERVICE, Nice-Pak Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Witch hazel 50%

Purpose

Astringent

Uses

helps relieve the local itching and discomfort associated with hemorrhoids
temporary relief of irritation and burning
aids in protecting irritated anorectal areas

Warnings

For external uses only

When using this product

do not exceed the recommended daily dosage unless directed by a doctor
do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

bleeding occurs
condition worsens or does not improve within 7 days

Keep out of reach of children

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

Directions

adult: 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 hemorrhoidal treatments, and then discard
children under 12 years of age: consult a doctor

Other informations

store at room temperature 20-25C (68-77F)
for vaginal care - cleanse the are by gently wiping, patting, or blotting. Repeat as needed.
for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. leave in place for 15 minutes and repeat as needed.

Inactive Ingredients

Water, Glycerine, Propylene Glycol, Sodium Citrate, Citric Acid, Iodopropynyl Butylcarbamate, Disodium Cocoamphodiacetate, 2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Juice, PEG-75 Lanolin

PRINCIPAL DISPLAY PANEL

SPL UNCLASSIFIED SECTION

Maximum Strength Formula

Compare To The Active Ingredient of Preparation H
Flushable and septic safe
Contains Aloe

48 Pre-moistened
Medicated Wipes
5.0 x 6.0 in (12.7 x 15.2 cm)

• Mild, everyday wipes to ease and lessen irritation
• Cooling, soothing, gentle, soft
• Convenient, easy to use
• For hemorrhoidal and vaginal care

INGREDIENTS AND APPEARANCE

PRE-MOISTENED MEDICATED WIPESHEMORRHOIDAL WIPEHEMORRHOIDAL WIPEHEMORRHOIDAL WIPEHEMORRHOIDAL WIPE  HEMORRHOIDAL WIPES WITH WITCH HAZEL
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34)	witch hazel	129 g  in 258 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
BRONOPOL (UNII: 6PU1E16C9W)
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)
PEG-75 LANOLIN (UNII: 09179OX7TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-500-48	48 in 1 CONTAINER
1		258 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/01/2013

Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)

Registrant - Nice-Pak Products, Inc. (003778198)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, Inc.		003778198	manufacture(55301-500)