FDA Label for 1168
View Indications, Usage & Precautions
1168 Product Label
The following document was submitted to the FDA by the labeler of this product Dynarex Corporation. 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 Hydrochloride 2%
Purpose
Topical Analgesic
Use(S)
For the temporary relief of pain associated with minor burns
Warnings
For External Use Only
Do Not Use
• Over large areas of the body, particularly over raw surfaces, or blistered areas
• Near eyes. If contact occurs, rinse thoroughly with water.
Stop Use And Ask A Doctor If
Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• Adults and children 12 years of age and older: Spray an even layer of burn spray over cleaned, affected area not more than 3 to 4 times daily.
• Children under 12 years of age: Consult a doctor before use
Other Information
• Store at 20°-25°C (68°-77°F)
Inactive Ingredients
Glycerin, Hydroxypropyl Methyl Cellulose, Melaleuca Alterniflia (Tea Tree) Leaf Oil, Octoxynol 9, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Triethanolamine
Questions?
1-888-Dynarex Monday - Friday, 9AM - 5PM EST
Label
1168 Label
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