HARMON FACE VALUES MEDICATED WIPES  - witch hazel cloth 
HARMON STORES INC.

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% v/v...........................................................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

Harmon Stores Inc.

550 Liberty Ave.

Union, NJ 07083

Visit us at www.facevalue.com

Made in China

image of carton labelEnter section text here

HARMON FACE VALUES MEDICATED WIPES  
witch hazel cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-802
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
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-802-4848 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/31/2012
Labeler - HARMON STORES INC. (804085293)

Revised: 7/2012
Document Id: 85d20f19-0ac1-4d2d-843f-87c695877f05
Set id: b4b4842a-0a99-4b7b-b355-319d90252186
Version: 4
Effective Time: 20120731
 
HARMON STORES INC.