Label: TERRASIL BACK PAIN CREAM- menthol cream
- NDC Code(s): 24909-199-01
- Packager: Aidance Skincare & Topical Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 10, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Product label
-
INGREDIENTS AND APPEARANCE
TERRASIL BACK PAIN CREAM
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-199 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 4 g in 100 g Inactive Ingredients Ingredient Name Strength COTTONSEED OIL (UNII: H3E878020N) JOJOBA OIL (UNII: 724GKU717M) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) OLIVE OIL (UNII: 6UYK2W1W1E) WATER (UNII: 059QF0KO0R) SAGE OIL (UNII: U27K0H1H2O) SHEA BUTTER (UNII: K49155WL9Y) ZINC OXIDE (UNII: SOI2LOH54Z) SORBIC ACID (UNII: X045WJ989B) SILVER OXIDE (UNII: 897WUN6G6T) PANTHENOL (UNII: WV9CM0O67Z) CETYL STEARATE (UNII: 06RI5UQA7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-199-01 44 g in 1 JAR; Type 0: Not a Combination Product 07/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/28/2021 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 018950611 manufacture(24909-199) , label(24909-199)