Drug Facts
Active Ingredient- Methanol 2 %
Purpose- External Pain Reliever
Menthol Pain Relieving Gel
FDA Label NDC 13709-357
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Menthol Pain Relieving Gel (NDC 13709-357). 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 drug facts, uses, warnings, do not use, ask a doctor before use, stop use and ask a doctor if, when using this product, if prgenant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporary relief of minor pains of muscle and joints associated with
- simple backache
- arthritis
- sprains, strains or bruises
Warnings
For External Use Only.
Avoid Contact with eyes.
Do Not Use
Internally
with heating pads or devices
on wound or damaged skin
Ask A Doctor Before Use
if have sensitive skin
Stop Use And Ask A Doctor If
condition worses
symptoms last more than 7 days, oe clear up and occur again within a few days
redness or irritaion develops
When Using This Product
Use Only as Directed
do not bandage tightly
Avoid contact within eyes and mucos membranes
If Prgenant Or Breast Feeding
Ask a healthcare professional before use
Keep Out Of The Children
Incase of accidental ingestion, get medical help or contact a poison control center immediately
Directions
Adults and Childern 2 years and older
Clean skin thoroughly.
Apply liberally to affected area not more than3-4 times daily.
No Protective cover needed.
May be used with ice packs.
May be used with wet or dry bandages, but wrap loosely.
Childern under 2 years of age.
Other Information
Store 59°-86°F (15°-30°C)
Keep tightly closed
Do not use, pour, spill or store near heat or open flame.
Store 59°-86°F (15°-30°C)
Keep tightly closed
Do not use, pour, spill or store near heat or open flame.
Other Ingredients
Camphor
Carbomer
FD&C Blue #1
Isopropyl Alcohol
Propylene Glycol
Purified Water
Sodium Hydroxide
Indications
Cooling, Pain relieving gel for muscle aches
arthiritis pain
simple backache
Dosage And Administration
Menthol 2 %
Therapeutic
Greaseless
Net Wt- 8 FL OZ (227 g)
Package Label
NeilMed Menthol Pain Relieving Gel
Therapeutic
Greeseless
Cooling, pain, relieving gel for muscle aches,
arthiritis pain,
Simple backache
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