FDA Label for Leader Medicated Wipes
View Indications, Usage & Precautions
Leader Medicated Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Otc - Ask Doctor/Pharmacist
Otc - When Using
Otc - Stop Use
Otc - Pregnancy Or Breast Feeding
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
Otc - Questions
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®.
* Please review the disclaimer below.