Other
Drug Facts
Healthwise Soothing Lidocaine Pain Relief Gel
FDA Label NDC 71101-986
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 Soothing Lidocaine Pain Relief (NDC 71101-986). 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 other, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCI 0.5%
Purpose
- Topical Analgesic
Uses
Uses Temporary relief of pain and itching associated with:
■ minor burns
■ sunburn
■ minor cuts
■ scrapes
■ insect bites
■ minor skin irritations
Warnings
For external use only
Directions
Directions
Adults and children 2 years of age and older: ■ apply a thin film over affected area not more than 3 to 4 times daily
Children under 2 years of age: ■ do not use, ask a doctor
Other Information
- store in a cool dry place
Inactive Ingredients
Aloe barbadensis leaf juice, carbomer, disodium EDTA, ethylhexylglycerin, FD&C blue no.1, FD&C yellow no.5, glycerin, maltodextrin, menthol, phenoxyethanol, polysorbate 20, propanediol, SD alcohol, sodium hydroxide, water
When Using This Product, Do Not
When using this product avoid contact with eyes or mucous membranes
Do Not Use
Do not use in large quantities over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
Stop use and ask a doctor if condition worsens, if symptoms last more than 7 days or clear up and reoccur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
* Please review the disclaimer below.
