The following Structured Product Label (SPL) was submitted to the FDA by H And P Industries, Inc. Dba Triad Group for the product Relief Towelette (NDC 50730-5400). 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 active ingredient, purpose, use, warnings, do not, otc - ask doctor/pharmacist, otc - when using, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient
Purpose
Use
For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids.
Warnings
For external use only.Avoid contact with eyes.
Do Not
Put this product into the rectum using fingers or any mechanical device or applicator.
Otc - Ask Doctor/Pharmacist
Otc - When Using
Stop Use And Ask A Doctor
- if condition worsens or does not improve within 7 days
- in case of bleeding
- before exceeding the recommended dosage.
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
- 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.
- Children under 12 years of age: consult a doctor.
Other
Store at room temperature 15° -30° C (59° - 86° F)
Inactive Ingredients
Citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water
Otc - Questions
Cat. No. 10-5400NDC 50730-5400-0ReliefMedicated hemorrhoidal towelettesComfort, soothe, cool - pH balancedTriad Group, Inc.700 West North Shore DriveHartland, WI 53029 USAMade in USAwww.triad-group.net100 Towelettes
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