View Drug - First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel
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First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel

Generic: LIDOCAINE HYDROCHLORIDE

100%
Basic Information
Manufacturer
Acme United Corporation
Product Type
HUMAN OTC DRUG
Route of Administration
TOPICAL
FDA Set ID
5258cef2-0e5c-4ccd-e063-6394a90a9e5c
Purpose
Purpose External Analgesic
Indications & Usage
Use for the temporary relief of pain associated with • minor burns
Warnings
Warnings For external use only Avoid Contact with eyes Do not use • on wounds or damaged skin • in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • symptoms 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.

(1-800-222-1222)
Technical Data
{
    "spl_product_data_elements": [
        "First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel LIDOCAINE HYDROCHLORIDE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) GLYCERIN IMIDUREA METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER TEA TREE OIL TROLAMINE CARBOMER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS"
    ],
    "spl_unclassified_section": [
        "Drug Facts Drug Facts",
        "Other information \u2022store at room temperature 15-30\u00b0C (59-86\u00b0F)"
    ],
    "active_ingredient": [
        "Active ingredient Lidocaine Hydrochloride 2% Purpose External Analgesic"
    ],
    "purpose": [
        "Purpose External Analgesic"
    ],
    "indications_and_usage": [
        "Use for the temporary relief of pain associated with \u2022 minor burns"
    ],
    "warnings": [
        "Warnings For external use only Avoid Contact with eyes Do not use \u2022 on wounds or damaged skin \u2022 in large quantities, particularly over raw surfaces or blistered areas Stop use and ask a doctor if \u2022 condition worsens or symptoms persist for more than 7 days \u2022 symptoms 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. (1-800-222-1222)"
    ],
    "do_not_use": [
        "Do not use \u2022 on wounds or damaged skin \u2022 in large quantities, particularly over raw surfaces or blistered areas"
    ],
    "stop_use": [
        "Stop use and ask a doctor if \u2022 condition worsens or symptoms persist for more than 7 days \u2022 symptoms 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. (1-800-222-1222)"
    ],
    "dosage_and_administration": [
        "Directions \u2022 adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily \u2022 children under 2 years of age: do not use consult a doctor"
    ],
    "inactive_ingredient": [
        "Inactive ingredients acrylates/C10-30 alkyl acrylate crosscopolymer, carbomer, glycerin, imidurea, methylparaben, propylene glycol, propylparaben, purified water, tea tree oil, trolamine"
    ],
    "questions": [
        "Questions? 800-835-2263"
    ],
    "package_label_principal_display_panel": [
        "Package Labeling: Carton Label"
    ],
    "set_id": "5258cef2-0e5c-4ccd-e063-6394a90a9e5c",
    "id": "5258cc02-81e4-3363-e063-6294a90a82e5",
    "effective_time": "20260521",
    "version": "1",
    "openfda": {
        "application_number": [
            "M003"
        ],
        "brand_name": [
            "First Aid Only Lidocaine Hydrochloride Analgesic Burn Gel"
        ],
        "generic_name": [
            "LIDOCAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
            "Acme United Corporation"
        ],
        "product_ndc": [
            "0924-5004"
        ],
        "product_type": [
            "HUMAN OTC DRUG"
        ],
        "route": [
            "TOPICAL"
        ],
        "substance_name": [
            "LIDOCAINE HYDROCHLORIDE"
        ],
        "spl_id": [
            "5258cc02-81e4-3363-e063-6294a90a82e5"
        ],
        "spl_set_id": [
            "5258cef2-0e5c-4ccd-e063-6394a90a9e5c"
        ],
        "package_ndc": [
            "0924-5004-00",
            "0924-5004-01",
            "0924-5004-03",
            "0924-5004-17"
        ],
        "original_packager_product_ndc": [
            "61040-230"
        ],
        "upc": [
            "0738743130103"
        ],
        "unii": [
            "V13007Z41A"
        ]
    }
}