{
"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": "2026-10-28",
"results": {
"skip": 0,
"limit": 1,
"total": 1
}
},
"results": [
{
"spl_product_data_elements": [
"DG Anti-Itch Diphenhydramine hydrochloride and Zinc acetate Diphenhydramine hydrochloride diphenhydramine Zinc acetate zinc cation CETOSTEARYL ALCOHOL polysorbate 60 DMDM HYDANTOIN GLYCERYL MONOSTEARATE ISOPROPYL MYRISTATE PHENOXYETHANOL mineral oil Sodium Benzoate WATER"
],
"spl_unclassified_section": [
"Drug Facts",
"DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE GOODLETTSVILLE, TN 37072"
],
"active_ingredient": [
"Active ingredients Purposes Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Uses Temporarily relieves pain and itching associated with: insect bites minor burns sunburn scrapes minor skin irritations minor cuts Dries the oozing and weeping of poison ivy, poison oak and poison sumac"
],
"warnings": [
"Warnings For external use only. Avoid contact with eyes. Do Not Use more than directed on large areas of the body with any product containing diphenhydramine even one taken by mouth Ask a doctor before use on chicken pox on measles 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222."
],
"do_not_use": [
"Do Not Use more than directed on large areas of the body with any product containing diphenhydramine even one taken by mouth"
],
"ask_doctor": [
"Ask a doctor before use on chicken pox on measles"
],
"stop_use": [
"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"
],
"pregnancy_or_breast_feeding": [
"If pregnant or breast-feeding, ask a health professional before use."
],
"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: 800-222-1222."
],
"dosage_and_administration": [
"Directions do not use more than directed adults and children 2 years of age and older: apply to affected area up to 4 times daily children under 2 years of age: ask a doctor"
],
"storage_and_handling": [
"Other information store at 15 to 30°C (59 to 86°F) contents filled by weight, not volume Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING."
],
"inactive_ingredient": [
"Inactive ingredients cetearyl alcohol (and) polysorbate 60, DMDM hydantoin, glyceryl stearate, isopropyl myristate, mineral oil, phenoxy ethenol, purified water, sodium benzoate"
],
"questions": [
"Questions or comments? 1-888-309-9030"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 28 g Tube Carton DG™|health NDC 55910-344-24 Compare to active ingredients of Benadryl ® Extra Strength Cream* Extra Strength Anti-Itch Cream Topical Analgesic and Skin Protectant Relieves Itches From Insect Bites & Skin Irritations NET WT 1 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Carton"
],
"set_id": "6be1c137-3c40-429f-b588-189db2cf46d7",
"id": "4710b60a-3269-45c1-a4aa-cab4fea0fe59",
"effective_time": "20241217",
"version": "4",
"openfda": {}
}
]
}