{
"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": "2026-10-29",
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{
"spl_product_data_elements": [
"Caladryl Clear PRAMOXINE HYDROCHLORIDE and ZINC ACETATE CAMPHOR (SYNTHETIC) CITRIC ACID MONOHYDRATE DIAZOLIDINYL UREA GLYCERIN METHYLPARABEN POLYSORBATE 40 PROPYLENE GLYCOL PROPYLPARABEN WATER HYPROMELLOSE, UNSPECIFIED SODIUM CITRATE, UNSPECIFIED FORM PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC ACETATE ZINC CATION"
],
"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 Pramoxine HCl 1% Topical analgesic Zinc acetate 0.1% Skin protectant"
],
"active_ingredient_table": [
"| Active ingredients | Purpose |
|---|
| Pramoxine HCl 1% | Topical analgesic |
| Zinc acetate 0.1% | Skin protectant |
"
],
"purpose": [
"Active ingredients Purpose Pramoxine HCl 1% Topical analgesic Zinc acetate 0.1% Skin protectant"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| Pramoxine HCl 1% | Topical analgesic |
| Zinc acetate 0.1% | Skin protectant |
"
],
"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, citric acid, diazolidinyl urea, fragrance, glycerin, hypromellose, methylparaben, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate"
],
"questions": [
"Questions/Comments call 1-800-321-4576"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label Caladryl ® Clear ® Topical Analgesic ∙ Skin Protectant Lotion Drying Action PLUS Itch Relief 6 FL OZ (177 mL) label.jpg"
],
"set_id": "fca6f08b-7fa0-4ae6-bce3-61f3bcae4332",
"id": "24adc674-5fba-e779-e063-6294a90ad250",
"effective_time": "20241017",
"version": "5",
"openfda": {
"application_number": [
"M014"
],
"brand_name": [
"Caladryl Clear"
],
"generic_name": [
"PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE"
],
"manufacturer_name": [
"Bausch Health US, LLC"
],
"product_ndc": [
"0187-5466"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"PRAMOXINE HYDROCHLORIDE",
"ZINC ACETATE"
],
"rxcui": [
"1234546",
"1234552"
],
"spl_id": [
"24adc674-5fba-e779-e063-6294a90ad250"
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"spl_set_id": [
"fca6f08b-7fa0-4ae6-bce3-61f3bcae4332"
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"package_ndc": [
"0187-5466-06"
],
"is_original_packager": [
true
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"upc": [
"0301875466060"
],
"unii": [
"88AYB867L5",
"FM5526K07A"
]
}
}
]
}