LUMINA NATURES CREATION UNVEILED- menthol cream 
Cosmetic Specialty Labs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Incredient

Menthol, 4%

Purpose

Topical analgesic

Uses

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

Warnings

For external use only

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

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

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:

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

Inactive ingredients

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

3 oz roll-on

LUMINA NATURES CREATION UNVEILED 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-591
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CYANOCOBALAMIN (UNII: P6YC3EG204)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ALCOHOL (UNII: 3K9958V90M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
SORBITOL (UNII: 506T60A25R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-591-0390 mL in 1 CYLINDER; Type 0: Not a Combination Product05/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/03/2023
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-591) , pack(58133-591) , label(58133-591)

Revised: 5/2023
Document Id: f5c4c3c0-62f8-c3d9-e053-2995a90a0b41
Set id: f5c4c351-2710-3c30-e053-2995a90adeb7
Version: 1
Effective Time: 20230503
 
Cosmetic Specialty Labs, Inc.