Otc - Active Ingredient
Lidocaine HCl 4% w/w
Lidocaine 4% Cream
FDA Label NDC 71457-505
11 label sections · Submitted to the FDA by Invaderm Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Invaderm Corporation for the product Lidocaine 4% Cream (NDC 71457-505). 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 - do not use, stop use and ask a doctor if, otc - keep out of reach of children, directions, 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
temporarily relieves pain and itching due to
■ minor cuts ■ minor scrapes ■ minor burns
■ sunburn ■ minor skin irritation ■ insect bites
Warnings
For external use only
Otc - Do Not Use
Do not use
■ in or near the eyes ■ in large quantities, particularly over raw or blistered areas
Stop Use And Ask A Doctor If
■ allergic reaction occurs
■ condition worsens or does not improve within 7 days
■ symptoms clear up and return within a few days
■ redness, irritation, swelling, pain or other symptoms begin or increase
Otc - 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.
Directions
■ Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
■ Children under 2 years of age: Consult a doctor.
Other Information
■ May be applied under occlusive dressing
■ Store at room temperature 20-25°C (68-77°F) Excursions permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Inactive Ingredient
Benzyl Alcohol, Carbomer, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.
Package Label.Principal Display Panel
NDC 71457-505-15
Lidocaine 4%
Topical Anesthetic Cream
NET WT 15 grams
15g (Lido 4 15g)
NDC 71457-505-30
Lidocaine 4%
Topical Anesthetic Cream
NET WT 30 grams
30g (Lido 4 30g)
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