Active Ingredient
Menthol 10%
Pain Relief
FDA Label NDC 82075-430
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sagely Enterprises Inc. for the product Pain Relief (NDC 82075-430). 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, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol 10%...................Topical Analgesic
Uses
temporarily relieves the minor aches and pains of muscles and joints associated with:
- strains
- bruises
- simple backache
- arthritis
- sprains
Warnings
For external use only.
Otc - Do Not Use
Do not use
- on wounds or damaged, broken, or irritated skin
- with a heating pad
Otc - When Using
When using this product
- avoid contact with eyes or mucous membranes
- do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, 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 right away.
Directions
- Use only as directed
- 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
Inactive Ingredients
SD Alcohol 40-B, Water, Sambucus Nigra Fruit Extract, Boswellia Serrata Extract, Camphor, Mentha Piperita Oil, Glycerin, Arnica Montana Flower Extract
Package Label.Principal Display Panel
Sagely Naturals
Extra Strength
Pain Relief Spray
95% Natural Ingredients
Instant Cooling
with 10% Menthol
2 Fl Oz / 60 mL
* Please review the disclaimer below.
