Label: LEADER MEDICATED WIPES- witch hazel solution
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-625-67 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 15, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
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DIRECTIONS
Adults and children
12 years and olderUp to 6 times daily or after
each bowel movementChildren 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
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OTHER USES
- for vaginal care - cleanse the area by gently wiping, patting or blotting with pad and discard. Repeat as needed.
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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
- QUESTIONS
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PACKAGE INFORMATION - LABEL
NDC 37205-625-67
LEADER®Compare to Preparation H® active ingredient*
PRE-MOISTENED
Medicated Wipes
Hemorrhoidal Wipes with Witch Hazel
- Cools, soothes and provides temporary relief of itching, burning and irritation
- For use with hemorrhoids and for vaginal care
- Convenient, easy to use
- Flushable
with Aloe
48 Wipes
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
CIN 4246294 www.myleader.com 1-800-200-6313*This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark PREPARATION H®.
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INGREDIENTS AND APPEARANCE
LEADER MEDICATED WIPES
witch hazel solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-625 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:37205-625-67 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 - Cardinal Health (097537435)