FDA Label for Pain Relief Gel-roll On
View Indications, Usage & Precautions
Pain Relief Gel-roll On Product Label
The following document was submitted to the FDA by the labeler of this product Shanghai Chuangshi Medical Technology (group) Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)
Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)
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
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