Label: TERRASIL BALANITIS RELIEF (sulfur, symphytum officinale- comfrey ointment
- NDC Code(s): 24909-119-14, 24909-119-15, 24909-119-44, 24909-119-50
- Packager: Aidance Skincare & Topical Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 29, 2018
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- Active Ingredient
- Purpose
- Uses
- KEEP OUT OF REACH OF CHILDREN
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 14g Tube
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INGREDIENTS AND APPEARANCE
TERRASIL BALANITIS RELIEF
sulfur, symphytum officinale (comfrey) ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 1 [hp_X] in 1 g SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y) SYMPHYTUM OFFICINALE WHOLE 1 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) BENTONITE (UNII: A3N5ZCN45C) CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60) COCONUT OIL (UNII: Q9L0O73W7L) COTTONSEED OIL (UNII: H3E878020N) JOJOBA OIL (UNII: 724GKU717M) LAVENDER OIL (UNII: ZBP1YXW0H8) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) SILVER OXIDE (UNII: 897WUN6G6T) STEARIC ACID (UNII: 4ELV7Z65AP) WHITE WAX (UNII: 7G1J5DA97F) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-119-14 14 g in 1 JAR; Type 0: Not a Combination Product 06/10/2014 2 NDC:24909-119-44 44 g in 1 JAR; Type 0: Not a Combination Product 06/10/2014 3 NDC:24909-119-15 14 g in 1 TUBE; Type 0: Not a Combination Product 12/29/2018 4 NDC:24909-119-50 50 g in 1 TUBE; Type 0: Not a Combination Product 12/29/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/10/2014 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-119) , label(24909-119)