FDA Label for Lidocaine
View Indications, Usage & Precautions
Lidocaine Product Label
The following document was submitted to the FDA by the labeler of this product Patrin Pharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
For external use only.
Active Ingredient
Lidocaine 4% w/w
Purpose
Topical anesthetic
Uses
temporarily relieves pain and itching due to
- minor cuts
- minor scrapes
- minor burns
- sunburn
- minor skin irritation
- insect bites
Directions
- Adult 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.
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.
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 Ingredients
Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.
Questions?
Call 800-936-3088
Principal Display Panel - 30 Gram Tube Carton
NDC 39328 - 024 - 30
Lidocaine 4%
Topical Anesthetic Cream
FOR EXTERNAL USE ONLY
PATRIN
PHARMA
Net Wt. 30 grams
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