Active Ingredient
Lidocaine 4%
Menthol 1%
Healthwise Roll-on Gel
FDA Label NDC 71101-110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Roll-on (NDC 71101-110). 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, when using this product, stop use and ask a doctor if, if pregnant or breast feeding, keep out of reach of children and pets., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use
For me temporary relief of pain and itching
Warnings
For External use only
Flammable keep away from fire or flame
When Using This Product
When using this product ■ avoid contact with eyes ■ do not use in large quantities, particularly over raw surfaces or blistered areas
■ do not appy to wounds or damaged skin ■ do not bandage tightly
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
■condition worsens
■symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast Feeding
ask a health professional before use.
Keep Out Of Reach Of Children And Pets.
Keep out of reach of children and pets. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.
Directions
■ Adults and children over 12 years: apply to affected area not more than 3 to 4 times daily.
■Children under 12 years or age: do not use, ask a doctor
Other Information
■ Store out of direct sunlight, in a cool dry, well-ventilated area. Do not store at temperature above above 120°F (49°C)
Inactive Ingredients
Aloe vera extract, carbomer, isopropyl myristate, lavender oil, phenoxyethanol, polysorbate 80, propylene glycol, tartaric acid, vitamin E, water
Questions Or Comments?
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