FDA.reportPublic FDA data

LUMINA Natures Creation UNVEILED

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2023-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:51

Label at a glance#

ProductLUMINA Natures Creation UNVEILED
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Dosage and administration

Adults and children 2 years of age and older: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 time daily Children under 2 years of age: ask a doctor effective date update and wording of Directions for Use updated to match label

Label contents#

Full prescribing information#

Active Incredient

OTC - ACTIVE INGREDIENT SECTION

Menthol, 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this prodcut•use only as directed •avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin •do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a physician if•condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days •redness is present •irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children . If case of accidental ingestion, get medical help or contact a poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:•apply generously to affected area •massage into painful area until thoroughly absorbed into skin •repeat as necessary, but no more than 4 time daily

Children under 2 years of age: ask a doctor

RECENT MAJOR CHANGES SECTION

effective date update and wording of Directions for Use updated to match label

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Barbadensis Leaf Juice, Arnica montana Flower Extract, Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cyanocobalamin, Mentha piperita (Peppermint) Leaf Oil, Methylsulfonylmethane, Phenoxyethanol, Polysorbate-60, Purified Water, Salix alba (Willow) Bark Extract, Sodium Hyaluronate, Sorbitol, Triethanolamine

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3 oz roll-on3 oz roll-on

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148430menthol 4 % Topical CreamPSN1
1148430menthol 40 MG/ML Topical CreamSCD1
1148430menthol 4 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-591-032024-07-30C16284748780-11e7a6dab-1985-a2ce-e063-dadaa90aadf7f5c4c351-2710-3c30-e053-2995a90adeb7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-591-03LUMINA Natures Creation UNVEILED90 mL in 1 CYLINDERCREAM901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-591LUMINA NATURES CREATION UNVEILED (MENTHOL) CREAM [COSMETIC SPECIALTY LABS, INC.]11 package rows20230504_f5c4c351-2710-3c30-e053-2995a90adeb7.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-59158133-591-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CYANOCOBALAMINP6YC3EG204IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ALCOHOL3K9958V90MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER 9404Q93RCW27EIACT
SALIX ALBA BARK205MXS71H7IACT
SORBITOL506T60A25RIACT
TROLAMINE9O3K93S3TKIACT
CETYL ALCOHOL936JST6JCNIACT
PEPPERMINT OILAV092KU4JHIACT
POLYSORBATE 60CAL22UVI4MIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
f5c4c3c0-62f8-c3d9-e053-2995a90a0b41f5c4c351-2710-3c30-e053-2995a90adeb72023-05-03WarningsExact identifier
spl id: f5c4c3c0-62f8-c3d9-e053-2995a90a0b41
spl set id: f5c4c351-2710-3c30-e053-2995a90adeb7

Reported adverse events (FAERS/openFDA)#

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