{"description":["DESCRIPTION Diclofenac 5%, Gabapentin 5%, Lidocaine HCl 2% For Pharmacy Prescription Compounding Only / Rx Only For Topical Use Only Each Dipentocaine™ Topical Cream Pharmacy Compounding Kit provides 5.7 grams of Diclofenac Sodium USP, 5.7 grams of Gabapentin USP, 2.28 grams of Lidocaine HCL USP, and 100.32 grams of Base. Diclofenac Sodium: CAS Number 15307-79-6 2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt Gabapentin: CAS Number 60142-96-3 1-(Aminomethyl)-cyclohexaneacetic acid, Neurontin Licocaine Hydrochloride Anhydrous: CAS Number 6108-05-0 2-Diethylamino-N-(2,6-dimethylphenyl)acetamide hydrochloride monohydrate, Lignocaine hydrochloride monohydrate, Xylocaine hydrochloride monohydrate Diclofenac Structure gabapentin structure lidocaine structure"],"effective_time":"20180311","how_supplied":["HOW SUPPLIED Kit Components: 5.7 g of Diclofenac Sodium, 5.7 g of Gabapentin, 2.28 g of Lidocaine Hydrochloride Anhydrous, and 100.32 g TDC Max Cream Base. Equipment needed: mill, spatula, mixing bowl, and Topi-Pump™. SIZE 114 grams NDC # 15455-7566-1 Dichlofenac Sodium, USP 5.7 grams Gabapentin, USP 5.7 grams Lidocaine HCL, USP 2.28 grams Base 100.32 grams For external use only. Avoid contact with eyes. Keep container tightly closed. Keep out of reach of children. Protect from light. Dispose of product after 30 days of being compounded. The FDA has not approved Alvix-Dipentocaine™ Topical Cream Compounding Kit to cure, treat, or mitigate disease. Alvix-Dipentocaine™ Topical Cream intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only. Certificate of analysis on file Rx ONLY Marketed by: Alvix Laboratories, LLC 1(888) 526-5449 Ocean Springs, MS 39564 Alvix Logo"],"how_supplied_table":["
SIZE 114 grams
NDC # 15455-7566-1
Dichlofenac Sodium, USP 5.7 grams
Gabapentin, USP 5.7 grams
Lidocaine HCL, USP 2.28 grams
Base 100.32 grams
"],"id":"672a4e9f-c91e-f5fc-e053-2a91aa0a6724","instructions_for_use":["INSTRUCTIONS FOR USE insert page 1 insert page 2"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 15455-7566-1 Dipentocaine ™ Topical Cream Diclofenac Sodium, Gabapentin, and Lidocaine Hydrochloride Compounding Kit FOR PHARMACY PRESCRIPTION COMPOUNDING ONLY / Rx Only Carton label"],"set_id":"b65dfc65-535b-4254-aeab-a3be3645b50c","spl_product_data_elements":["Dipentocaine Topical Cream Compounding Kit Diclofenac Sodium, Gabapentin, and Lidocaine Hydrochloride Diclofenac Sodium Diclofenac Sodium DICLOFENAC SODIUM DICLOFENAC Gabapentin Gabapentin GABAPENTIN GABAPENTIN Lidocaine Hydrochloride Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE TDC Max Cream Base Cream Base WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 PEG-150 STEARATE STEARETH-20 CYCLOMETHICONE 5 ETHYLHEXYL STEARATE SORBITOL ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE EDETATE DISODIUM METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE"],"spl_unclassified_section":["CONTAINER LABELS diclofenac label gabapentin label lidocaine label cream label"],"storage_and_handling":["STORAGE AND HANDLING Prior to compounding, store Alvix- Dipentocaine™ Topical Cream Compounding Kit at room temperature between 20 - 25 degrees C (68 - 77 degrees F). Protect from light."],"version":"4","warnings":["WARNING Diclofenac jSodium: Pictogram Signal word: Danger Hazard statement(s): H301 Toxic if swallowed. Precautionary statement(s): P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician. P321 Specific treatment (see supplemental first aid instructions on this label). P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/ container to an approved waste disposal plant. Gabapentin: Pictograms: Signal word: Danger Hazard statement(s): H315 Causes skin irritation. H319 Causes serious eye irritation. H335 May cause respiratory irritation. H360 May damage fertility or the unborn child. Precautionary statement(s): P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray. P264 Wash skin thoroughly after handling. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/ eye protection/ face protection. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P321 Specific treatment (see supplemental first aid instructions on this label). P332 + P313 If skin irritation occurs: Get medical advice/ attention. P337 + P313 If eye irritation persists: Get medical advice/ attention. P362 Take off contaminated clothing and wash before reuse. P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P405 Store locked up. P501 Dispose of contents/ container to an approved waste disposal plant. Lidocaine Hydrochloride Anhydrous: Pictogram Signal word: Danger Hazard statement(s): H301 Toxic if swallowed. Precautionary statement(s): P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER or doctor/ physician. P321 Specific treatment (see supplemental first aid instructions on this label). P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/ container to an approved waste disposal plant. skull and cross bones pictogram Health Hazard Pictogram exclamation point pictogram health hazard pictogram pictogram pictogram"]}