FDA Label for Lidocaine Cream
View Indications, Usage & Precautions
Lidocaine Cream Product Label
The following document was submitted to the FDA by the labeler of this product Invernis Pharmaceuticals, 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.
Active Ingredient
Lidocaine 4%
Purposes
Topical Analgesic
Uses
For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.
Warnings
- For External Use only
- Avoid contact with the eyes.
- Do not use in large quantities, particularly over raw surfaces or blistered areas.
- condition worsens or if symptoms persist for more than 7 days
- or occur again within a few days.
Stop Use and Ask a Doctor if
Directions
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: Do not use, consult a doctor.
Other Information
- Store at room temperature, 20 – 25°C (68-77°F).
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE,Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate-20,Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.
Product Label
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