Label: TRICALM HYDROGEL- aluminum acetate gel
- NDC Code(s): 71207-100-10, 71207-100-20
- Packager: Modular Thermal Technologies LLC Dba Life Wear Technologies
- Category: HUMAN OTC DRUG LABEL
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 March 23, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 60 mL Vertical Carton
- Principal Display Panel Tube
-
INGREDIENTS AND APPEARANCE
TRICALM HYDROGEL
aluminum acetate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71207-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B) ALUMINUM ACETATE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DEHYDROACETIC ACID (UNII: 2KAG279R6R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCINE (UNII: TE7660XO1C) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MALIC ACID (UNII: 817L1N4CKP) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71207-100-10 1 in 1 CARTON 11/02/2016 1 60 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71207-100-20 1 in 1 CARTON 11/02/2016 2 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 11/01/2013 Labeler - Modular Thermal Technologies LLC Dba Life Wear Technologies (131710969) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(71207-100)