{"active_ingredient":["Active ingredient Calamine 8% Pramoxine HCl 1%"],"dosage_and_administration":["DIRECTIONS • Shake well before use • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • Children under 2 years of age: ask a doctor"],"effective_time":"20230208","id":"f42ad874-1142-1ea4-e053-2995a90a9e03","inactive_ingredient":["INACTIVE INGREDIENTS SD Alcohol 38-B, Camphor, Diazolidinyl urea, Fragrance, Hypromellose, Methylparaben, Polysorbate 80, Propylene glycol, Propylparaben, Purified water, Xanthan gum"],"indications_and_usage":["USES • Temporarily relieves pain and itching associated with: • Rashes due to poison ivy, • Poison oak or poison sumac • Insect bites • Minor skin irritation • Minor cuts • Dries the oozing and weeping of poison ivy, poison oak and poison sumac"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Packaging Calamine Pramoxine HCl-1"],"purpose":["Purpose Skin protectant Topical analgesic"],"questions":["QUESTIONS/COMMENTS Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST."],"set_id":"5dd9a3f3-227b-440e-8867-3e0187f86093","spl_product_data_elements":["L-Topical CALAMINE 8% PRAMOXINE HCL 1% Calamine, Pramoxine Hydrochloride ALCOHOL CAMPHOR (SYNTHETIC) DIAZOLIDINYL UREA HYPROMELLOSE, UNSPECIFIED METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER XANTHAN GUM ZINC OXIDE ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE"],"spl_unclassified_section":["DRUG FACTS","Calamine Plus Itch Reliever Manufactured by : Global Pharma Healthcare Pvt. Ltd., A-9, SIDCO Pharmaceutical Complex, Alathur-603 110 - INDIA. www.global-pharma.com"],"storage_and_handling":["OTHER INFORMATION Store at 20° to 25°C (68° to 77°F)"],"version":"2","warnings":["WARNINGS For external use only. When using this product do not get into eyes Stop use and ask a doctor if • Condition worsens or does not improve within 7 days • Symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}