NDC | 58133-211-03 |
Set ID | 84af0590-db35-2b23-e053-2a91aa0a89c0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cosmetic Specialty Labs, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Active ingredient
- Purpose
- Uses
- Warnings
- Allergy Alert
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Inactive ingredients:
- Package Labeling
-
INGREDIENTS AND APPEARANCE
TEDS TOPICAL PAIN GEL ROLL ON
trolamine salicylate 10% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-211 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER 940 (UNII: 4Q93RCW27E) CYCLOMETHICONE (UNII: NMQ347994Z) TRIETHANOLAMINE ISOSTEARATE (UNII: T8OTU5ECY5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z) SALIX ALBA BARK (UNII: 205MXS71H7) BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) WATER (UNII: 059QF0KO0R) RESVERATROL (UNII: Q369O8926L) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-211-03 85 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 03/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/21/2019 Labeler - Cosmetic Specialty Labs, Inc. (032973000) Registrant - Cosmetic Specialty Labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty Labs, Inc. 032973000 manufacture(58133-211)