Active Ingredient
Menthol 2.5%
Pain-x Gel
FDA Label NDC 80489-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ol Pharma Tech,llc for the product Pain-x (NDC 80489-003). 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, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
temporarily relieves the minor aches and pains of muscles and joints associated with:
- simple backaches
- arthritis
- strains
- bruises
- sprains
Warnings
for external use only
Do Not Use
Do not use
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions
Ask A Doctor Before Use
Ask a doctor before use if you have redness over the affected area.
When Using This Product
- avoid contact with eyes or mucous membranes
- do not bandage tightly
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occurs
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
Other Information
- store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
Vitamin E, Propylene glycol,Polysorbate 80,Water, Isopropyl alcohol,Carbomer interpolymer typ A, edta, Methylparaben, Propylparaben.
Questions
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