Active Ingredient
Lidocaine 4%
Enokon Pain Relief Spray. Spray
FDA Label NDC 83559-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Enokon Medical Instrument Co., Ltd. for the product Enokon Pain Relief Spray. (NDC 83559-018). 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, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TOPICAL ANESTHETIC
Use
temporarily relieves minor pain
Warnings
For external use only
Do Not Use
*on large areas of the body or on cut, irritated or swollen skin
*on puncture wounds
*for more than one week without consulting a doctor
When Using
*use only as directed, read and follow all directions and warnings on this label
*do not allow contact with the eyes and mucous membranes
*avoid spraying on face
*avoid inhalation of spray
*do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
*do not use at the same time as other topical analgesics
Stop Use
*condition worsens
*redness is present
*irritation develops
*symptoms persist for more than 7 days or clear up and occur again within a few days
Ask Doctor
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children over 12 years:
*spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period
*product will dry quickly on its own, and does not need to be rubbed in
children 12 years or younger: ask a doctor
Other Information
Store at controlled room temperature 68°–77°F (20°–25°C)
Inactive Ingredients
light mineral oil, methylparaben sodium, peg-32 monostearate, peg-6 monostearate, sorbic acid, stearyl alcohol, water
Questions
Questions or comments?
Call 1 858 905 0218
Principal Display Panel
1 (30g)
2 (50g)
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