Premier Value Medicated Pads
FDA Label NDC 70108-029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios, Inc. for the product Premier Value Medicated Pads (NDC 70108-029). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, 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
Indications & Usage
Use Temporarily relieves these external symptoms associated with hemorrhoids:
• itching • burning • irritation
Warnings
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.
Dosage & Administration
Directions: As hemorrhoidal treatments 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
Storage And Handling
Other Information Store at 20° to 25°C (68° to 77°F)
Inactive Ingredient
Inactive Ingredients alcohol, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water
Packaging
Image Description (Label2.1)
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