Active Ingredient
Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)
Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)
Pain Relief Gel-roll On Gel
FDA Label NDC 73557-373
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Chuangshi Medical Technology (group) Co., Ltd. for the product Pain Relief Gel-roll On (NDC 73557-373). 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 this product, stop use if, ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
(Lidocaine) Topical Anesthetic
(Menthol) Topical Analgesic
Use
temporary relief of pain
Warnings
For external use only
Do Not Use
• on large areas of the body or on cut, irritated or swollen skin not apply to wounds or damaged skin • on puncture wounds • for more than one week without consulting a doctor
When Using This Product
• use only as directed. Read and follow all directions and warnings on this label • do not allow contact with eyes and mucous membranes • do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use • do not use at the same time as other topical analgesics
Stop Use If
• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days
Ask A Doctor If
• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days
Flammable
• keep away from fire or flame
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 12 over years:
• apply a thin layer to affected area 6 to 8 hours, not to exceed 3 application in a 24 hour period
Children under 12 years of age: Consult a doctor
Inactive Ingredients
Aloe Vera Extract, Carbopol, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water
Questions Or Comments
86-21-31166566
General Precautions
Child-resistant packaging. Close cap tightly after use.
Package Label.Principal Display Panel
Container Label (373 0)
Package Label (373 1)
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