Otc - Active Ingredient
Active ingredient : Menthol 5%
Advanced Pain Relief Roll-on Gel With 5% Natural Menthol Gel
FDA Label NDC 62742-4279
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Advanced Pain Relief Roll-on Gel With 5% Natural Menthol (NDC 62742-4279). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Topical analgesic
Indications & Usage
Uses:
For the temporary relief of minor aches and pains of muscles and joints associated with
simple backache
arthritis
strains
bruises
sprains
Warnings
Warnings:
For external use only.
Otc - Do Not Use
Do not use on wounds or damaged skin
Otc - When Using
When using this product
avoid contact with eyes
do not bandage tight
Otc - Stop Use
Stop use and ask a doctor if
condition worsens
irritation occurs
symptoms persist for more than 7 days or clear up and occur again within a few days
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
Dosage & Administration
Directions:Shake well before each use.
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
Children under 2 years: Do not use, consult a doctor.
Other Safety Information
Other Information:
If pregnant or nursing, ask a health professional before use.
Store in a cool, dry place away from light
Inactive Ingredient
Inactive ingredients:
Water (Aqua), Ethoxydiglycol, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Carbomer, Pyridoxine HCI, Dimethyl Sulfone, Sodium Hydroxide, Ethylhexylglycerin, Cetyl Esters, Glycerin, Cetyl Myristoleate, Cetyl Myristate, Arnica Montana Flower Extract, Cinnamomum Camphora (Camphor) Bark Oil, Boswellia Serrata Oil, Sodium Ascorbyl Phosphate, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Oil, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Limonene, Linalool, Camphor, Alpha-Terpinene, Terpinolene, Terpineol, Pinene, Eugenol.
Package Label.Principal Display Panel
Advanced Pain Relief Roll On Gel With Menthol (Advancedpainreliefrollongel)
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