LUMINA NATURES CREATION UNVEILED- menthol cream

LUMINA Natures Creation UNVEILED by

Drug Labeling and Warnings

LUMINA Natures Creation UNVEILED by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

LUMINA NATURES CREATION UNVEILED 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-591
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-591-03	90 mL in 1 CYLINDER; Type 0: Not a Combination Product	05/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/03/2023

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-591) , pack(58133-591) , label(58133-591)