Active Ingredient
Lidocaine Hydrochloride 2%
1168 Spray
FDA Label NDC 67777-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product 1168 (NDC 67777-013). 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 active ingredient, purpose, use(s), warnings, do not use, stop use and ask a doctor if, 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
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_in_master (1168 In Master R240215 1)
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