FDA Label for Leader Medicated Wipe

View Indications, Usage & Precautions

Leader Medicated Wipe 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.

Otc - Active Ingredient



Active ingredient                                                                       Purpose

Witch Hazel, 50% v/v................................................................Astringent


Otc - Purpose



Uses

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


Warnings



For external use only.  Avoid contact with eyes.


Otc - Ask Doctor



Consult a doctor

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

Otc - Do Not Use



Do not put this product into rectum using fingers or any mechanical device or applicator


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



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


Storage And Handling



Other information

Store at room temperature: 15o-30oC (59o-86oF)


Inactive Ingredient



Inactive ingredients

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


Dosage & Administration



DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4246294

www.myleader.com

1-800-200-6313

Made in China


Package Label.Principal Display Panel




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