Label: TERRASIL FLEX PAIN RELIEF AND MUSCLE RUB- menthol cream
- NDC Code(s): 24909-191-44
- 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 July 22, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TERRASIL FLEX PAIN RELIEF AND MUSCLE RUB
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24909-191 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL STEARATE (UNII: 06RI5UQA7L) SHEA BUTTER (UNII: K49155WL9Y) COTTONSEED OIL (UNII: H3E878020N) SORBIC ACID (UNII: X045WJ989B) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) JOJOBA OIL (UNII: 724GKU717M) SAGE OIL (UNII: U27K0H1H2O) PANTHENOL (UNII: WV9CM0O67Z) OLIVE OIL (UNII: 6UYK2W1W1E) STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) SILVER OXIDE (UNII: 897WUN6G6T) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24909-191-44 44 g in 1 JAR; Type 0: Not a Combination Product 08/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/06/2019 Labeler - Aidance Skincare & Topical Solutions, LLC (018950611) Establishment Name Address ID/FEI Business Operations Aidance Skincare & Topical Solutions, LLC 018950611 manufacture(24909-191) , label(24909-191)