PREMIER VALUE MEDICATED WIPES- witch hazel cloth

PREMIER VALUE MEDICATED WIPES by

Drug Labeling and Warnings

PREMIER VALUE MEDICATED WIPES 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

For temporary relief of local discomfort itching, burning, and irritation associated with hermorrhoids

WARNINGS

Warnings

For external use only.  Avoid contact with eyes.

ASK DOCTOR

Consult a doctor

• if condition worsens or does not improve within 7 days
• in case of bleeding
• before exceeding the recommended dosage
  

WHEN USING

Do not put this product into rectum using fingers or any mechanical device or applicator.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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

Adults and children 12 years and older- Up to 6 times daily or after each bowel movement

Children under 12- Consult a doctor

When practical, cleanse 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 each application of this product. 

Gently apply to the affected area by patting and discard.  Apply to the affected area up to 6 times daily or after each bowel movement.

STORAGE AND HANDLING

Store at room temperature: 15o-30oC (59o-86oF)

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis gel, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

DOSAGE & ADMINISTRATION

Distributed By

Meijer Distribution, Inc.

2929 Walker Ave. NW

Grand Rapids, MI 49544

www.meijer.com

Made in China

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PREMIER VALUE MEDICATED WIPES 
witch hazel cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-409
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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-409-93	48 in 1 POUCH
2	NDC: 68016-409-94	2 in 1 CARTON
2		96 in 1 POUCH

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