Active Ingredient
Sulfur 1X HPUS
Symphytum Officinale (Comfrey) 1X HPUS
Terrasil Balanitis Relief Ointment
FDA Label NDC 24909-119
7 label sections · Submitted to the FDA by Aidance Scientific, Inc., Dba Aidance Skincare & Topical Solutions · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidance Scientific, Inc., Dba Aidance Skincare & Topical Solutions for the product Terrasil Balanitis Relief (NDC 24909-119). 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, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, principal display panel - 14g & 50g tubes, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sulfur - Rash Relief
Symphytum Officinale - Inflammatory Relief
Uses
Helps relieve irritated skin at the head of the penis.
Warnings
For external use only. When using this product do not use in or near eyes. Stop use and ask a doctor if symptoms last more than 3 days, symptoms worsen, or symptoms clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, call Poison Control or seek medical help right away.
Directions
Adults and children 2 years of age and older: Apply to affected area 2 to 3 times per day or as needed. Children under 2 years of age: Consult a doctor. Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.
Inactive Ingredients
allantoin, beeswax, cedarwood oil, cottonseed oil, jojoba oil, lavender oil, magnesium oxide, MCT Oil, silver stearate, zinc oxide.
* Please review the disclaimer below.
