Quality Choice Medicated Wipes
FDA Label NDC 15533-396
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 Wipes (NDC 15533-396). 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, uses, 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
Anorectal/Astringent
Uses
• temporarily relieves the local itching and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas • temporarily relieves irritation and burning
Warnings
For external use only
When using this product
• do not use more than directed unless told to do so by a doctor
• do not put directly in the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
• rectal bleeding occurs
• condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few 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 (1-800-222-1222) right away.
Directions
• open the lid on the top of the wipes pouch • peel back wipes seal, remove completely and discard
• grab the top wipe at the edge of the center fold and pull out of pouch
• close lid after each use to retain moisture
• adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area
• use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard. Do Not Flush.
• children under 12 years of age: consult a doctor
Other Information
• store at room temperature 20-25°C (68-77°F) • protect from excessive heat
Inactive Ingredients
alcohol, aloe vera leaf, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
Packaging
Medicated Wipes (1553339601 3)
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