FDA.reportPublic FDA data

dermaFIT Muscle Retention Cream Sculpt

Manufacturer
EX Healthcare Inc. | Kolmar Korea Co.,Ltd
Effective date
2026-02-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:46:51

Label at a glance#

ProductdermaFIT Muscle Retention Cream Sculpt
Active ingredientMENTHOL
Label structure12 sections

Dosage and administration

• Apply to affected area not more than 3 to 4 times daily. • Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 0.1%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

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 SECTION

For external use only.

OTC - DO NOT USE SECTION

to wounds or damaged skin.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes and
mucous membranes.

OTC - STOP USE SECTION

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 SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

• Apply to affected area not more than 3 to 4 times daily.
• Children under 12 years of age: consult a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82679-113-01dermaFIT Muscle Retention Cream Sculpt200 mL in 1 BOTTLE, PLASTICCREAM2002
82679-113-02dermaFIT Muscle Retention Cream Sculpt1 in 1 BOXCREAM12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82679-11382679-113-01, 82679-113-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-10 DIISOSTEARATE84YE9R8P8TIACT
GLYCERINPDC6A3C0OXIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PROPANEDIOL5965N8W85TIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETEARYL ALCOHOL2DMT128M1SIACT
SILICAETJ7Z6XBU4IACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
CARBOMER0A5MM307FCIACT
ARGININE94ZLA3W45FIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
BETAINE3SCV180C9WIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYALURONATEYSE9PPT4THIACT
TOCOPHEROLR0ZB2556P8IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
MENADIONE723JX6CXY5IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CENTELLA ASIATICA LEAF6810070TYDIACT
MENTHOLL7T10EIP3AACTIB
AQUA059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-17monthly-update2026-06-03 17:46:05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dermaFIT Muscle Retention Cream SculptMENTHOLEX Healthcare Inc.4620d4ca-42e4-eeae-e063-6394a90a5c842026-02-23WarningsExact identifier
ndc (package): 82679-113-02
ndc (package): 82679-113-01
ndc (product): 82679-113
ndc11 (package): 82679011302
ndc11 (package): 82679011301
spl id: 4b7474b2-1029-1a9f-e063-6394a90a5c32
spl set id: 4620d4ca-42e4-eeae-e063-6394a90a5c84

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.