Active Ingredient
Cocoa Butter 50%
Terrasil Fissures Formula
FDA Label NDC 24909-118
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 Skincare & Topical Solutions, Llc for the product Terrasil Fissures Formula (NDC 24909-118). 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 - 14g label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
For the temporary relief of local itching and discomfort in the perianal area, associated with anorectal disorders. Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues. Temporarily protects irritated areas. Temporarily relieves burning.
Warnings
For external and/or intrarectal use only. When using this product do not exceed the recommended daily dosage unless directed by a doctor. Stop use and ask a doctor if - bleeding occurs - condition worsens or does not improve within 7 days. If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or call a Poison Control Center right away.
Directions
Adults: If practical, cleanse the affected area before use. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. Regular use provides continual therapy for relief of symptoms. Children under 12 years of age: ask a doctor.
Inactive Ingredients
beeswax (organic), bentonite (volcanic clay), calendula, chamomile, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, tea tree oil, zinc oxide.
Principal Display Panel - 14G Label
terrasil with Activated Minerals
Fissures Formula
Coats. Soothes. Protects.
Jar Label (Terrasil Fissures Label 14g 05122014)
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