Active Ingredient
Lidocaine HCL 4.0%
Pain Relief Gel-roll On Gel
FDA Label NDC 73557-363
16 label sections · Submitted to the FDA by Shanghai Chuangshi Medical Technology (group) Co., Ltd. · 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 73557-363). 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
Topical Anesthetic
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
• 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 again 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 again 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 applications in a 24 hour period
Children under 12 years of age: Consult a doctor
Inactive Ingredients
1,2-Hexanediol, Aminomethyl Propanol, Aloe Vera Extract, Butylene Glycol, Carbomer, Cetostearyl Alcohol, Dimethicone, Edetate Disodium, Glycerin, Glyceryl Mono- and Dipalmitostearate, Hydroxyacetophenone, Isopropyl Myristate, Polysorbate 80, Vitamin E, Water
Questions Or Comments
86-21-31166566
General Precautions
Child-resistant packaging. Close cap tightly after use.
Package Label.Principal Display Panel
Bottle (Bottle)
Box (Box)
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