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 Stratus 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.
Other
Drug Facts
Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use.
Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186
Active Ingredient
Lidocaine 4% (4g in 100g)
Purpose
Local analgesic
Uses
for the temporary relief of pain and itching associated with
- minor burns
- sunburn
- minor cuts
- scrapes
- insect bites
- minor skin irritations
Warnings
For external use only
When Using This Product
- avoid contact with the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Consult A Doctor If
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.
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 20°C to 25°C (68°F to 77°F)
Inactive Ingredients
acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.
Questions?
Call us at (800) 442-7882
Principal Display Panel - 28.35 G Tube Box
STRATUS
PHARMACEUTICALS INC
NDC 58980-824-30
Net WT. 1 oz. / 28.35 g
LIDOCAINE CREAM
4%
PAIN RELIEVING CREAM
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE
* Please review the disclaimer below.