{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-26", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Ivarest Zinc Oxide, Benzyl Alcohol, and Diphenhydramine Hydrochloride Zinc Oxide Zinc Oxide Benzyl Alcohol Benzyl Alcohol Diphenhydramine Hydrochloride Diphenhydramine bentonite benzethonium chloride lanolin alcohols lanolin oil magnesium aluminum silicate MENTHOL, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED petrolatum polyethylene glycol 200 polyglyceryl-3 diisostearate polysorbate 60 propylene glycol water D&C red no. 33 sorbitan monostearate squalane FD&C yellow no. 5 FD&C yellow no. 6 camphor (synthetic) povidone-iodine HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients Purpose Calamine 14.0 % (w/w) Skin protectant Benzyl Alcohol 10.5 % (w/w) External analgesic Diphenhydramine Hydrochloride 2.0 % (w/w) External analgesic" ], "active_ingredient_table": [ "
Active ingredientsPurpose
Calamine 14.0 % (w/w)Skin protectant
Benzyl Alcohol 10.5 % (w/w)External analgesic
Diphenhydramine Hydrochloride 2.0 % (w/w)External analgesic
" ], "purpose": [ "Active ingredients Purpose Calamine 14.0 % (w/w) Skin protectant Benzyl Alcohol 10.5 % (w/w) External analgesic Diphenhydramine Hydrochloride 2.0 % (w/w) External analgesic" ], "purpose_table": [ "
Active ingredientsPurpose
Calamine 14.0 % (w/w)Skin protectant
Benzyl Alcohol 10.5 % (w/w)External analgesic
Diphenhydramine Hydrochloride 2.0 % (w/w)External analgesic
" ], "indications_and_usage": [ "Uses for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations. dries the oozing and weeping of poison: ivy oak sumac" ], "warnings": [ "Warnings For external use only Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles When using this product do not get into eyes. Stop use and ask a doctor if condition worsens symptoms last 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." ], "do_not_use": [ "Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth" ], "ask_doctor": [ "Ask a doctor before use on chicken pox on measles" ], "when_using": [ "When using this product do not get into eyes." ], "stop_use": [ "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days" ], "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." ], "dosage_and_administration": [ "Directions do not use more often than directed as soon as possible after exposure, wash affected area with soap and water (or Ivarest Poison Ivy Cleansing Foam). Gently pat dry. apply Ivarest liberally to form a layer you can not see through. adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor." ], "storage_and_handling": [ "Other information Avoid contact with clothing. Ivarest may stain certain fabrics." ], "inactive_ingredient": [ "Inactive ingredients bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, polyethylene glycol, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 56 g Tube Carton Long Lasting Cream NDC 10157-9077-1 MAXIMUM STRENGTH IVAREST ® EXTERNAL ANALGESIC/ POISON IVY, OAK, SUMAC DRYING CREAM POISON IVY ITCH CREAM 8 Hour Relief Double Relief Formula 1 Antihistamine helps stop the reaction 2 Analgesic soothes itch fast Plus ... Skin protectant to help dry the rash Poison Ivy, Oak & Sumac, Insect Bites, Minor Skin Irritations Net Wt. 2 oz. (56 g) PRINCIPAL DISPLAY PANEL - 56 g Tube Carton" ], "set_id": "6f68cbbb-6269-4bb3-8cc9-50b146703b42", "id": "3f9296ee-f86d-4ca4-922d-1b6926de869d", "effective_time": "20240709", "version": "3", "openfda": { "application_number": [ "M016" ], "brand_name": [ "Ivarest" ], "generic_name": [ "ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Blistex Inc" ], "product_ndc": [ "10157-9077" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "ZINC OXIDE", "BENZYL ALCOHOL", "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1298467" ], "spl_id": [ "3f9296ee-f86d-4ca4-922d-1b6926de869d" ], "spl_set_id": [ "6f68cbbb-6269-4bb3-8cc9-50b146703b42" ], "package_ndc": [ "10157-9077-1" ], "is_original_packager": [ true ], "nui": [ "N0000181811" ], "pharm_class_epc": [ "Pediculicide [EPC]" ], "unii": [ "SOI2LOH54Z", "LKG8494WBH", "TC2D6JAD40" ] } } ] }