Otc - Active Ingredient
MENTHOL 0.1%
Dermafit Muscle Retention Cream Sculpt Cream
FDA Label NDC 82679-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ex Healthcare Inc. for the product Dermafit Muscle Retention Cream Sculpt (NDC 82679-113). 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
Topical Analgesic
Indications & Usage
For the recovery of muscle post workout and the
temporary relief of minor aches and pains of muscles and
joints associated with sprains, arthritis, and strains.
Warnings
For external use only.
Otc - Do Not Use
to wounds or damaged skin.
Otc - When Using
When using this product avoid contact with eyes and
mucous membranes.
Otc - Stop Use
if condition worsens, symptoms
persist for more than 7 days or clear up and occur again
within a few days.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get
medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional
before use.
Inactive Ingredient
Water, Propanediol, Glycerin, Butylene Glycol, Cetyl
Ethylhexanoate, 1,2-Hexanediol, Camellia Japonica Flower
Extract, Sorbitan Olivate, Cetearyl Glucoside, Cetearyl
Olivate, Betaine, Arginine, Sodium Hyaluronate, Carbomer,
Silica, Ethylhexylglycerin, Cetearyl Alcohol
Other Safety Information
Store at room temperature.
Directions
• Apply to affected area not more than 3 to 4 times daily.
• Children under 12 years of age: consult a doctor.
* Please review the disclaimer below.
