PREMIER VALUE MEDICATED WIPES - witch hazel cloth 
CHAIN DRUG CONSORTIUM, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient                                                              Purpose

Witch Hazel, 50% ...........................................................Astringent

Uses

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

Warnings

For external use only.  Avoid contact with eyes.

Consult a doctor

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

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

Keep out of reach of children.

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

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.

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

Inactive ingredients

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

Distributed By

Meijer Distribution, Inc.

2929 Walker Ave. NW

Grand Rapids, MI 49544

www.meijer.com

Made in China

image of carton labelEnter section text here

PREMIER VALUE MEDICATED WIPES 
witch hazel cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL5 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-409-9348 in 1 POUCH
2NDC:68016-409-942 in 1 CARTON
296 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/01/2011
Labeler - CHAIN DRUG CONSORTIUM, LLC (101668460)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
AMERICAN HYGIENICS CORPORATION545198454manufacture

Revised: 6/2011
Document Id: 97a6cb83-eff3-4cb0-a548-cf26269031ee
Set id: 8486ac20-6948-4913-8791-38f363b7cc72
Version: 1
Effective Time: 20110601
 
CHAIN DRUG CONSORTIUM, LLC