MEDICATED WIPES- witch hazel solution

Medicated Wipes by

Drug Labeling and Warnings

Medicated Wipes by is a Otc medication manufactured, distributed, or labeled by Triad Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 then discard. Apply to the affected area up to 6 times daily or after each bowel movement.

OTHER INFORMATION

• Store at room temperature: 15°- 30° C (59° - 86° F)
• For best results, flush only one wipe at a time
  

OTHER USES

• for vaginal care - cleanse the area  by gently wiping, patting or blotting with pad and discard. Repeat as needed.
• for use as a moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
  

INACTIVE INGREDIENTS

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

QUESTIONS

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®.

INGREDIENTS AND APPEARANCE

MEDICATED WIPES 
witch hazel solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50730-7993
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
witch hazel (UNII: 101I4J0U34) (witch hazel - UNII:101I4J0U34)	witch hazel	0.50 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50730-7993-1	48 in 1 PACKAGE
1		4.5 mL in 1 APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/13/2010

Labeler - Triad Group (050259597)