Active Ingredient
LIDOCAINE HYDROCHLORIDE 4%
Enokon Pain Relief Cream
FDA Label NDC 83559-017
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 Cream (NDC 83559-017). 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
*if you have serious foot problems, such as ulcers or infections, 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 carton.
*do not allow contact with the eyes and mucus membranes
*do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the 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: Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period, massage into painful area until thoroughly absorbed into skin
*Children 12 years or younger: ask a doctor
Other Information
Store at controlled room temperature 68°–77°F (20°–25°C)
Inactive Ingredients
pegoxol-7 stearate, cetyl alcohol, light mineral oil, ethylparaben, water
Questions
Questions or comments?
Call 1 858 905 0218
Principal Display Panel
1 (50g)
2 (60g)
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