Otc - Active Ingredient
Benzyl alcohol 10%
Lidocaine HCl 4%
Thermacare Max Strength Lidocaine Spray
FDA Label NDC 69693-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clarion Brands Llc for the product Thermacare Max Strength Lidocaine (NDC 69693-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, inactive ingredient, otc - questions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical anesthetic
Indications & Usage
Use
- for the termporary relief of pain
Warnings
For external use only
Flammable
- contents under pressure
- keep away from fire, sparks, and heated surfaces
- do not puncture or incinerate
- exposure to temperatures above 130°F may cause bursting
- in large quantities
- on wounds, damaged, broken, or irritated skin
- for more than one week without consulting a doctor
- use only as directed. Read and follow all directions and warnings on this label
- avoid contact with the eyes and mucous membranes
- do not bandage tightly or apply local heat such as a heating pad or a medicated patch
- do not use with other topical analgesics
- rash or irritation develops
- symptoms worsen or persist for more than 7 days or clear up and occur again within a few days
Do not use
When using this product
Stop use and ask a doctor if
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.
Otc - When Using
- adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
- children under 2 years of age: consult a doctor before use
Inactive Ingredient
1,2 hexanediol
alcohol
aloe barbadensis leaf juice
aminomethyl propanol
bisabolol
caprylyl glycol
disodium EDTA
isopropyl alcohol
propylene glycol
vanillyl butyl ether
water
zingiber officinale (ginger) root extract
Otc - Questions
1-800-323-3383
Dosage & Administration
Benzyl alcohol 10%
Lidocaine HCl 4%
Otc - Keep Out Of Reach Of Children
Directions
adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
children under 2 years of age: consult a doctor before use.
Package Label.Principal Display Panel
NEW! ThermaCare Heat Therapy
Soothing Heat 2x Dual Action Maximum Lidocaine
Heat + Max Strength Lidocaine Pain Relief
Fast Acting, Long Lasting
Penetrates to the Source
Number 1 Doctor Recommended
Spray NET WT 3oz (85g)
No Mess Application - 360 Degree Spray
Distributed by: Bridges Consumer Healthcare
811 Broad Street, Suite 600, Chattanooga, TN 37402
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