Medicated-pads Hemorrhoidal Pads With Witch Hazel
FDA Label NDC 44019-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yinjing Medical Technology (shanghai) Co., Ltd. for the product Medicated-pads Hemorrhoidal Pads With Witch Hazel (NDC 44019-001). 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 medicated-pads hemorrhoidal pads with witch hazel, active ingredient, purpose, use, warnings, consult a doctor, keep out of reach of children., directions, 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% v/v
Purpose
Astringent
Use
For temporary relief of local discomfort itching, burning, and irritation associated with hermorrhoids.
Warnings
For external use only. Avoid contact with eyes.
Consult A Doctor
- If condition worsens or does not improve within 7 days.
- In case of bleeding.
- Before exceeding the recommended dosage.
- Do not put this product into rectum using fingers or any mechanical device or applicator.
Keep Out Of Reach Of Children.
Directions
? As a hemorrhoidal treatment for adults and children 12 years of age and older.
? 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 Information
Store at room temperature 15
0 - 30
0 C (59
0 - 86
0 F)
Inactive Ingredients:
Purified Water, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Diazolidinyl Urea, Methyl Paraben, Propyl Paraben, Sodium Citrate, Citric Acid, Disodium EDTA.
Package Label.Principal Display Panel
NDC: 44019-001-00
MEDICATED-PADS Hemorrhoidal pads with Witch Hazel IN IN Shanghai Medical Supplies Co.,Ltd. Add: No.586 YuanXi Rd, Nanhui Industry Park, Pudong new area, Shanghai-201300.China. Tel:+86-(21)68016511 Fax:+86-(21)68016736 http://www.yinjing.cn E-mail:[email protected]
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