Otc - Active Ingredient
Active ingredient;
Menthol - 5%
Advanced Pain Relief Cream With 5 % Natural Menthol Cream
FDA Label NDC 62742-4278
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 Cream With 5 % Natural Menthol (NDC 62742-4278). 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 tightl
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 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, Coconut Alkanes, Helianthus Annuus (Suflower) Seed Oil, Glyceryl Stearate, Cetyl Esters, PEG-100 Stearate, Dimethicone, Stearic Acid, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Ceteareth-20, Phenoxyethanol, Steareth-20, Coco-Caprylate/Caprate, Glycerl Stearates, Caprylyl Glycol, Butyrospermum Parkii Nut Extract, Methyl Gluceth-20, Ethylhexylglycerin, Hexylene Glycol, Glycerin, Disodium EDTA, Amica Montana Flower Extract, Sodium Ascorbyl Phospahte, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Boswella Carterii (Frankincense) Oil, Mentha Piperita (Peppermint) Oil, Camphor, Limonene, Linalool, Alpha-Terpinene, Terpineol, Terpinolene, Pinene, Eugenol.
* Please review the disclaimer below.
