{
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"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": [
"BALMEX MULTI-PURPOSE Petrolatum Petrolatum Petrolatum Vachellia Farnesiana Flower Allantoin Aloe Vera Leaf Chamomile Cholecalciferol Cyclomethicone 5 Cyclomethicone 6 Dimethicone 200 Isopropyl Myristate Isopropyl Palmitate Lavandula Angustifolia Subsp. Angustifolia Flowering Top Mineral Oil High Density Polyethylene Vitamin A Palmitate Rosemary Silicon Dioxide .alpha.-tocopherol Acetate, Dl- Corn Oil"
],
"spl_unclassified_section": [
"Drug Facts",
"Other information do not use if quality seal is broken see bottom of tube for lot number and expiration date",
"Distributed by RANDOB LABS LTD. Box 440, Cornwall, NY 12518"
],
"active_ingredient": [
"Active ingredients Purpose Petrolatum 51.1% Skin protectant"
],
"active_ingredient_table": [
" | Active ingredients | Purpose |
| Petrolatum 51.1% | Skin protectant |
"
],
"purpose": [
"Active ingredients Purpose Petrolatum 51.1% Skin protectant"
],
"purpose_table": [
" | Active ingredients | Purpose |
| Petrolatum 51.1% | Skin protectant |
"
],
"indications_and_usage": [
"Uses temporarily protects minor cuts scrapes burns temporarily protects and helps relieve chapped or cracked skin helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness"
],
"warnings": [
"Warnings For external use only 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. Do not use on deep or puncture wounds animal bites serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
],
"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."
],
"do_not_use": [
"Do not use on deep or puncture wounds animal bites serious burns"
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
],
"dosage_and_administration": [
"Directions apply as needed change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged"
],
"storage_and_handling": [
""
],
"inactive_ingredient": [
"Inactive ingredients acacia farnesiana flower extract, allantoin, aloe barbadenis leaf extract, chamomilla recutita (matricaria) flower extract, cholecalciferol, cyclomethicone, dimethicone, fragrance, isopropyl myristate, isopropyl palmitate, lavandula angustifolia (lavender) extract, mineral oil, polyethylene, retinyl palmitate, rosmarinus officinalis (rosemary) extract, silica, tocopheryl acetate, zea mays (corn) oil (245-276)"
],
"questions": [
"Questions? 1-833-389-9450"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 99 g Tube Label NEW LOOK-SAME PRODUCT Balmex® MULTI-PURPOSE HEALING OINTMENT Skin Protectant-Petrolatum 51.1% From diaper rash to chapped, chafed skin ✔ Heals, protects & soothes ✔ 7 healing moisturizers plus Vitamin A & Vitamin D ✔ Clear and easy to apply Pediatrician Recommended NET WT 3.5 OZ (99 g) Principal Display Panel - 99 g Tube Label"
],
"set_id": "83a9ba1a-b708-47e2-a4a3-ef847e1bb792",
"id": "8460153a-29a3-4b1e-8e15-c1be1176e97c",
"effective_time": "20181113",
"version": "1",
"openfda": {
"application_number": [
"part347"
],
"brand_name": [
"BALMEX MULTI-PURPOSE"
],
"generic_name": [
"PETROLATUM"
],
"manufacturer_name": [
"Randob Labs,Ltd."
],
"product_ndc": [
"52412-450"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"PETROLATUM"
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"rxcui": [
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"1492071"
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"52412-450-35"
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"unii": [
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}
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