FDA.reportPublic FDA data

Aromalief Cozy Vanilla Pain Relief Cream

Manufacturer
Marketites LLC
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:41:13

Label at a glance#

ProductAromalief Cozy Vanilla Pain Relief Cream
Active ingredientMENTHOL
Label structure9 sections

Dosage and administration

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 of age: consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Menthol 1.0% w/w

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Use For temporary relief of pain

Warnings

WARNINGS SECTION

Warnings

For external use only. Avoid contact with eyes.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, or new symptoms occur.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional.

Directions

DOSAGE & ADMINISTRATION SECTION

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 of age: consult a doctor.

Ohter Information

OTHER SAFETY INFORMATION

Store in a cool dry place between 68º and 77ºF and relative humidity not exceeding 65%.

Do not use if seal is broken, torn or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Water, Stearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glyceryl Stearate, Menthyl Lactate, Glycerin, PEG 100 Stearate, Cannabis Sativa Seed Oil, Ulva lactuca Linnaeus, Fucaceae Fucus Vesiculosus, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Oil, Fragrance, Lavandula Angustifolia (Lavender) Flower Oil, Maltodextrin, Glucosamine Sulfate, Dimethyl Sulfone (MSM), L-Arginine, Glycol Stearate, Phenoxyethanol, Caprylyl Glycol

Questions

OTC - QUESTIONS SECTION

Distributed by Marketites LLC

Coral Gables, FL 33134

Made in the USA

Questions? info@aromalief.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aromalief Cozy Vanilla Pain Relief CreamAromalief Cozy Vanilla Pain Relief Cream

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130661646159646GTIN-13: 0661646159646
EAN-13: 0661646159646
GTIN-12: 661646159646
UPC-A: 661646159646
GTIN storage (14 digits): 00661646159646		Aromalief Vanilla FDA Labels.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
72393-303-04Aromalief Cozy Vanilla Pain Relief Cream0.14 g in 1 TUBELOTION0.142

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72393-30372393-303-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ALMOND OIL66YXD4DKO9IACT
PEG-100 STEARATEYD01N1999RIACT
FUCUS VESICULOSUS535G2ABX9MIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
MENTHOLL7T10EIP3AACTIB
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
GLYCERINPDC6A3C0OXIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ARGININE94ZLA3W45FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCOL STEARATE0324G66D0EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
ULVA LACTUCAPHR3P25W6YIACT
ALOE VERA LEAFZY81Z83H0XIACT
FRAGRANCE 135765EM498GW35IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-05-28full-release2026-06-01 01:01:40

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
Aromalief Cozy Vanilla Pain Relief CreamMENTHOLMarketites LLC3634e55e-8c62-a782-e063-6394a90a65082025-10-29WarningsExact identifier
ndc (package): 72393-303-04
ndc (product): 72393-303
ndc11 (package): 72393030304
spl id: 424fef4b-8291-610a-e063-6294a90a711a
spl set id: 3634e55e-8c62-a782-e063-6394a90a6508

Reported adverse events (FAERS/openFDA)#

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