Active Ingredient
Menthol 10%
Healthwise Pain Relieving Cream
FDA Label NDC 71101-076
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 Pain Relieving Cream (NDC 71101-076). 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 and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Use
Use For the temporary relief of minor aches and pains of muscle and joints associated with
■ simple backache
■ arthritis
■ strains
■ bruises
■ sprains
Warnings
For external use only.
Do Not Use
on wounds or damaged skin
When Using This Product
■ avoid contact with they eyes
■ do not bandage tightly
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.
If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.
Directions
Adults and children 2 years of age and older: ■ apply to 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 at room temperature
Inactive Ingredients
alcohol, butylene glycol, calcium gluconate, caprylic/capric triglyceride, caprylyl glycol, cetearyl alcohol, dimethicone, gluconolactone, glycerin, glyceryl stearate, ilex paraguariensis leaf extract, isopropyl alcohol, lavandula angusttifolia (lavender) oil, PEG-4 dilaurate, PEG-100 stearate, phenoxyethanol, polysorbate 60, sodium hydroxide, tetrasodium EDTA, tocopheryl acetate, vitis vinifera (grape) seed oil, water, xanthan gum
* Please review the disclaimer below.
