Active Ingredient
Menthol 10%
Pain Relief Roll-on
FDA Label NDC 82075-420
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 Roll-on (NDC 82075-420). 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:
- arthritis
- sprains
- muscle strains
- bruises
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 if 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
- apply a thin layer to affected area
- massage into painful area
- repeat as necessary, but no more than 3 to 4 times daily
- Children 12 years or younger: ask a doctor.
Adults and children over 12 years:
Inactive Ingredients
Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco-Caprylate, Glyceryl Stearate, Glyceryl Stearate Citrate, Diheptyl Succinate, Glycerin, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Microcrystalline Cellulose, Cellulose Gum, Phytic Acid, Leuconostoc/Radish Root Ferment Filtrate, Boswellia Serrata Resin Extract, Polyglyceryl-6 Caprylate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Cocoate, Polyglyceryl-6 Ricinoleate, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Camphor, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Lavender (Lavandula Hybrida) Oil, Peppermint (Mentha Piperita) Oil, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid
Package Label.Principal Display Panel
Sagely Naturals
Pain Relief Roll-On
Instant Cooling
With 10% Menthol
95% Natural Ingredients
2 FL OZ / 60 ML
1 (0001)
2 (0002)
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