{"description":["DESCRIPTION Naproxen 10% External Cream Base For Pharmacy Prescription Compounding Only / Rx Only Each Equipto - Naproxen External Cream Compounding Kit provides 12 grams of Naproxen powder for incorporation into 108 grams of a Base. The resulting mixture is intended for topical use. CAS #22204-53-1 (S)-6-methoxy-.alpha.-methyl-2-naphthaleneacetic acid structure"],"effective_time":"20180312","how_supplied":["KIT COMPONENTS Kit Components: 1 color coded pink bottle of 12g Naproxen, 1 bottle of 108g Base, 1 stirring rod, and 1 empty white mixing jar. SIZE 120 grams NDC # 15455-0601-1 Naproxen 12 grams TDC Max Cream Base 108 grams * Certificate of analysis on file. The FDA has not approved Equipto - Naproxen External Cream Compounding Kit to cure, treat, or mitigate disease. Equipto - Naproxen External Cream Compounding Kit is intended for preparation in accordance with state and federal regulation governing compounding and is available to patients by prescription only. Rx ONLY Marketed by: Alvix Laboratories, LLC 6601 Sunplex Drive Ocean Springs, MS 36564 1-888-526-5449 www.Alix.com logo"],"how_supplied_table":["<table> <colgroup> <col width=\"319\"/> <col width=\"319\"/> </colgroup> <tbody> <tr> <td styleCode=\"Lrule Rrule Toprule\">SIZE</td> <td styleCode=\"Lrule Rrule Toprule\">120 grams</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">NDC #</td> <td styleCode=\"Lrule Rrule Toprule\">15455-0601-1</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">Naproxen</td> <td styleCode=\"Lrule Rrule Toprule\">12 grams</td> </tr> <tr> <td styleCode=\"Lrule Rrule Toprule\">TDC Max Cream Base</td> <td styleCode=\"Lrule Rrule Toprule\">108 grams</td> </tr> </tbody> </table>"],"id":"673dc8db-6266-c569-e053-2a91aa0ae7f6","instructions_for_use":["INSTRUCTION FOR USE Instructions Page 1 Instructions page 2"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 15455-0610-2 Equipto - Naproxen External Cream Compounding Kit Naproxen 10% External Cream in Base FOR PRESCRIPTION COMPOUNDING ONLY Rx Only 120 grams as dispensed carton label","Naproxen USP Powder Label 12 g NDC# 15455-0601-1 FOR PRESCRIPTION COMPOUNDING ONLY Rx Only Naproxen Label 12 g","TDC MAX Cream - Base 108 g NDC# 15455-0999-1 FOR PRESCRIPTION COMPOUNDING ONLY Rx Only Base Label 108 g"],"set_id":"26d8f813-c55a-4417-8d5d-7761c1f3ebe6","spl_product_data_elements":["Equipto - Naproxen External Cream Compounding Kit Naproxen Naproxen Naproxen NAPROXEN NAPROXEN 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"],"storage_and_handling":["STORAGE AND HANDLING Precautions To Be Taken in Handling: Avoid breathing dust/fume/gas/mist/vapours/spray. Avoid prolonged or repeated exposure. Prior to compounding, store Equipto - Naproxen External Cream Compounding Kit at room temperature between 15 - 30 degrees C (59 - 86 degrees F). Protect from light. For external use only. Avoid contact with eyes. Keep container tightly closed. Keep out of reach of children. Protect from light. Dispose of the product after 30 days of being compounded."],"version":"4","warnings":["WARNING Pictogram GHS Signal Word: Danger GHS Hazard Phrases: H302: Harmful if swallowed. H319: Causes serious eye irritation. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects. GHS Precaution Phrases: P264: Wash {hands} thoroughly after handling. P280: Wear {protective gloves/protective clothing/eye protection/face protection}. P261: Avoid breathing {dust/fume/gas/mist/vapours/spray}. P273: Avoid release to the environment GHS Response Phrases: P301+312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. P330: Rinse mouth. P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+313: If eye irritation persists, get medical advice/attention. P304+340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P312: Call a {POISON CENTER/doctor/...} if you feel unwell. skull and cross bones pictogram health hazard pictogram"]}