{
"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": "2026-08-11",
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"spl_product_data_elements": [
"Visine A.C. Itchy Eye Relief Tetrahydrozoline Hydrochloride and Zinc Sulfate, Unspecified Form BENZALKONIUM CHLORIDE BORIC ACID EDETATE DISODIUM WATER SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE ZINC SULFATE, UNSPECIFIED FORM ZINC CATION"
],
"spl_unclassified_section": [
"Drug Facts",
"Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
],
"active_ingredient": [
"Active ingredients Purpose Tetrahydrozoline HCl 0.05% Redness reliever Zinc sulfate 0.25% Astringent"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Use for temporary relief of discomfort and redness of the eye due to minor eye irritations"
],
"warnings": [
"Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma. When using this product pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination replace cap after each use some users may experience a brief tingling sensation Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours 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."
],
"ask_doctor": [
"Ask a doctor before use if you have narrow angle glaucoma."
],
"when_using": [
"When using this product pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination replace cap after each use some users may experience a brief tingling sensation"
],
"stop_use": [
"Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours"
],
"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."
],
"dosage_and_administration": [
"Directions put 1 to 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age: ask a doctor children under 2 years of age: do not use"
],
"storage_and_handling": [
"Other information store at 15° to 25°C (59° to 77°F)"
],
"inactive_ingredient": [
"Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate"
],
"questions": [
"Questions? call toll-free 888-734-7648 or 215-273-8755 (collect)"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton VISINE ® A.C. ITCHY EYE RELIEF ASTRINGENT / REDNESS RELIEVER EYE DROPS RELIEVES ITCHY, RED, WATERY EYES STERILE 1/2 FL OZ (15mL) Principal Display Panel - 15 mL Bottle Carton"
],
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"id": "21d8bf17-920a-739e-e063-6294a90a2882",
"effective_time": "20241113",
"version": "3",
"openfda": {
"application_number": [
"M018"
],
"brand_name": [
"Visine A.C. Itchy Eye Relief"
],
"generic_name": [
"TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM"
],
"manufacturer_name": [
"Kenvue Brands LLC"
],
"product_ndc": [
"69968-0366"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"substance_name": [
"TETRAHYDROZOLINE HYDROCHLORIDE",
"ZINC SULFATE, UNSPECIFIED FORM"
],
"rxcui": [
"1043249"
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"spl_id": [
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"69968-0366-1"
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"89DS0H96TB"
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}
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