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HealthWise 2X Medicated Pain Relief Cream Roll-on
Healthwise 2x Medicated Pain Relief Cream Roll-on Cream
FDA Label NDC 71101-071
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 2x Medicated Pain Relief Cream Roll-on (NDC 71101-071). 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, 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
Active Ingredient
Menthol 10%
Methyl Salicylate 20%
Purpose
Topical analgesic
Topical analgesic
Uses
temporarily relieves minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- strains
- sprains
- bruises
Warnings
For external use only
When Using This Product
- use only as directed. Read and follow all directions and warnings on this carton.
- avoid contact with eyes and mucous membranes
- rare cases of serious burns have been reported with products of this type
- do not apply to wounds or damaged, broken or irritated skin
- do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- do not expose the area treated with product to heat or direct sunlight
- avoid applying into skin folds
Stop Use And 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
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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 (1-800-222-1222) right away.
Do Not Use
On wounds of damaged skin
Directions
adults and children 2 years and older:
- apply to affected area not more than 3 to 4 times daily.
children under 2 years of age: do not use, consult a doctor
Inactive Ingredients
acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, arnica montana flower extract, capsaicin, cetearyl alcohol, ethylhexylglycerin, maltodextrin, phenoxyethanol, potassium cetyl phosphate, propylene glycol, tocopheryl acetate, water
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