Quality Choice Medicated Pads
FDA Label NDC 15533-395
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Hygienics Corporation for the product Quality Choice Medicated Pads (NDC 15533-395). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Witch Hazel, 50%
Purpose
Astringent
Use
Temporarily relieves these external symptoms associated with hemorrhoids:
• itching • burning • irritation
Warnings
For external use only. Avoid contact with eyes.
When using this product • do not exceed the recommended daily dosage unless directed by a doctor. • do not put directly into rectum by using fingers or any mechanical device.
Stop use and ask a doctor if • Rectal bleeding occurs • Condition worsens or does not improve within 7 days
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.
Directions:
As hemorrhoidal treatment for adults:
• When practical, clean 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 applying.
• Gently apply to the affected area by patting and then discard.
• Can be used up to six times daily or after each bowel movement.
Children under 12 years of age: ask a doctor
Other Information
Store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water
Packaging
Image (1553339501)
* Please review the disclaimer below.
