FAMILY CARE MEDICATED HEMORRHOIDAL  - witch hazel cloth 
UNITED EXCHANGE CORPORATION

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

Temporarily relieves these external symptoms associated with hemorrhoids: itching, burning, irritation

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

Other information: store at 59o to 77oF

Inactive ingredient:

water, glycerin, alcohol, propylene glycol, sodium citrate, diazolidinyl urea, citric acid, methylparaben, and propylparaben

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in China

image of carton labelEnter section text here

FAMILY CARE MEDICATED HEMORRHOIDAL  
witch hazel cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-802
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-802-098 in 1 CARTON
11 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/20/2011
Labeler - UNITED EXCHANGE CORPORATION (840130579)
Registrant - UNITED EXCHANGE CORPORATION (840130579)
Establishment
NameAddressID/FEIBusiness Operations
AMERICAN HYGIENICS CORPORATION545198454manufacture

Revised: 7/2011
Document Id: ab346b45-079f-48c4-94ec-1ccb12ffd229
Set id: 6a30595a-f864-4ff1-bba0-81ef27ef25b7
Version: 2
Effective Time: 20110720
 
UNITED EXCHANGE CORPORATION