{
"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",
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"spl_product_data_elements": [
"Caladryl Ferric Oxide Red, Zinc Oxide, and Pramoxine Hydrochloride CAMPHOR (SYNTHETIC) DIAZOLIDINYL UREA HYPROMELLOSE, UNSPECIFIED METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL PROPYLPARABEN WATER XANTHAN GUM FERRIC OXIDE RED FERRIC OXIDE RED ZINC OXIDE ZINC OXIDE PRAMOXINE HYDROCHLORIDE PRAMOXINE"
],
"spl_unclassified_section": [
"Drug Facts",
"Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA ©2020 Bausch Health Companies Inc. or its affiliates Rev. 01/2020 Made in Canada"
],
"active_ingredient": [
"Active ingredients Purpose Calamine 8% Skin protectant Pramoxine HCl 1% Topical analgesic"
],
"active_ingredient_table": [
"| Active ingredients | Purpose |
|---|
| Calamine 8% | Skin protectant |
| Pramoxine HCl 1% | Topical analgesic |
"
],
"purpose": [
"Active ingredients Purpose Calamine 8% Skin protectant Pramoxine HCl 1% Topical analgesic"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| Calamine 8% | Skin protectant |
| Pramoxine HCl 1% | Topical analgesic |
"
],
"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"
],
"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."
],
"when_using": [
"When using this product do not get into eyes"
],
"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"
],
"ask_doctor": [
"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": [
"Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
],
"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"
],
"storage_and_handling": [
"Other information store at 20° to 25°C (68° to 77°F)"
],
"inactive_ingredient": [
"Inactive ingredients SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum"
],
"questions": [
"Questions/Comments call 1-800-321-4576"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label Caladryl ® Topical Analgesic ∙ Skin Protectant Lotion Calamine Plus Itch Reliever 6 FL OZ (177 mL) label.jpg"
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"id": "24add3ce-a1f0-0b6a-e063-6394a90a77c2",
"effective_time": "20241017",
"version": "6",
"openfda": {
"application_number": [
"M014"
],
"brand_name": [
"Caladryl"
],
"generic_name": [
"FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE"
],
"manufacturer_name": [
"Bausch Health US, LLC"
],
"product_ndc": [
"0187-5465"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"FERRIC OXIDE RED",
"ZINC OXIDE",
"PRAMOXINE HYDROCHLORIDE"
],
"rxcui": [
"1234532",
"1234533"
],
"spl_id": [
"24add3ce-a1f0-0b6a-e063-6394a90a77c2"
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"package_ndc": [
"0187-5465-06"
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true
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"upc": [
"0301875465063"
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"unii": [
"1K09F3G675",
"SOI2LOH54Z",
"88AYB867L5"
]
}
}
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}