MEDICATED WIPES - witch hazel solution 
Triad Group

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

Witch Hazel 50% v/v

PURPOSE

Astringent

USE

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

WARNINGS

For external use only. Avoid contact with eyes.

Consult a doctor

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

Do not

put this product into rectum using fingers or any mechanical device or applicator






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 12Consult a doctor


OTHER INFORMATION

OTHER USES

INACTIVE INGREDIENTS

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


PACKAGE INFORMATION - LABEL

NDC 50730-7993-1
Compare to Preparation H® active ingredient*

CAREONE®

pre-moistened
MEDICATED WIPES
HEMORRHOIDAL WIPES WITH WITCH HAZEL WITH ALOE

Comforts, Soothes
Cools Irritated Tissue
Flushable

48 WIPES


Distributed by:
American Sales Company
4201 Walden Avenue
Lancaster, NY, 14086

©2010 S and S Brands, Inc,
www.Care1.info

Quality Guaranteed or your money back.

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark PREPARATION H®.




foil

label

MEDICATED WIPES 
witch hazel solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-7993
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34) witch hazel0.50 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
citric acid monohydrate (UNII: 2968PHW8QP)  
diazolidinylurea (UNII: H5RIZ3MPW4)  
glycerin (UNII: PDC6A3C0OX)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
sodium citrate (UNII: 1Q73Q2JULR)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50730-7993-148 in 1 PACKAGE
14.5 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/13/2010
Labeler - Triad Group (050259597)

Revised: 4/2010
Document Id: 3ab22487-f897-4f83-aef7-0c6ceae92c95
Set id: 590c36f7-d02c-4631-b452-057d13efe440
Version: 1
Effective Time: 20100415
 
Triad Group