Otc - Active Ingredient
Active ingredient
Purpose
Menthol (0.1%).......Topical analgesic
Topical Hemorrhoid Relief Gel
FDA Label NDC 87512-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yantai Aien Biotechnology Co., Ltd. for the product Topical Hemorrhoid Relief Gel (NDC 87512-005). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, 87512-005-01 topical hemorrhoid relief gel 15g, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For the temporary relief of localdiscomfort, itching, and pain in theperianal area associated with
hemorrhoids and other anorectal
disorders
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenIf swallowed, get medical help orcontact a Poison Control Centerright away.
Warnings
Warnings
For external use only
Do not useI If you are allergic to menthol orany other ingredient in this product
When using this productAvoid contact with eyes. Ifcontact occurs, rinse thoroughly
with waterDo not put this product into therectum by using fingers or anymechanical device or applicator
Stop use and ask a doctor ifCondition worsens or does notimprove within 7 days
Bleeding occursRedness, irritation, swelling, pain,or other symptoms develop or
increaseAllergic reaction occurs
Dosage & Administration
Apply externally to the affectedarea up to 6 times daily
Indications & Usage
DirectionsAdults: When practical, cleansethe affected area with mild soap
and warm water and rinsethoroughly. Gently dry by pattingor blotting with toilet tissue or asoft cloth before application of this
product.
Apply externally to the affectedarea up to 6 times daily
Children under 12 years of age:
consult a doctor
Inactive Ingredient
Inactive ingredients
Polihexanide, Riboflavin, Allantoin,
Sorbitol, Sodium Alginate,
Panthenol, Alkannin, Polyethylene
Glycol 200, Ferrous Sulfate,
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