Terrasil Balanitis Relief Ointment
FDA Label NDC 24909-119

Full FDA labeling including 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, keep out of reach of children., directions, inactive ingredients, principal display panel - 44g label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Sulfur 1X HPUS
Symphytum Officinale (Comfrey) 1X HPUS

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. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if - symptoms persists for more than 3 days - symptoms worsen - symptoms clear up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center 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.

Inactive Ingredients

allantoin, beeswax (organic), bentonite (volcanic clay), cedarwood oil, coconut oil, jojoba seed oil, lavender oil, magnesium oxide, silver oxide, zinc oxide.

Principal Display Panel - 44G Label

terrasil with Activated Minerals

Balanitis Relief
Soothes. Protects. Relieves.

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