LEVEL SELECT MENTHOL CAMPHOR ROLL ON- 10% menthol, 5% camphor roll on gel gel 
Kandenwood LLC

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Level Select 10% Menthol, 5% Camphor 2.5 oz Roll On Tube

OTC-ACTIVE INGREDIENTS

Menthol 10%

Camphor 5%

OTC-PURPOSE

Topical Analgesic

Uses

Temporary relief from minor aches and pains of muscles and joints, associated with strains, sprains,arthritis, backache, bruises

Warnings

For external use only

When using this product:

Stop use and ask a doctor if:

If pregnant or breastfeeding:

consult a physician before use

Keep out of reach of chlidren and pets

If accidentally ingested, please seek medical help

Directions:

Adults and Children 12 years and older:


_______________________________________________________________

Children under 12 years of age:

Other Information:

Store in a cool, dry place iwth lid closed tightly

Inactive Ingredients:

Aesculus Hippocastanum (Horse Chestnut) Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Beta-Caryophyllene, Blue #1, Caffeine, Caprylyl Glycol, Carbomer, Cymbopogon, Flexuosus (Lemongrass Oil), Glycerin, Methylsulfonylmethane (MSM), Oleth-3, Oleth-3 Phosphate, Phenoxyethanol, Polysorbate 80, Propanediol, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hydroxide, Symphytum Offcinate (Comfrey) Leaf Extract, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E) Triethanolamine, Water, Yellow #5

Level Select 10% Menthol, 5% Camphor 2.5 oz Tube Roll On

Level Select Roll On Gel 2.5 oz

LEVEL SELECT MENTHOL CAMPHOR ROLL ON 
10% menthol, 5% camphor roll on gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83191-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
OLETH-3 (UNII: BQZ26235UC)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
PROPANEDIOL (UNII: 5965N8W85T)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYMBOPOGON FLEXUOSUS LEAF (UNII: 7LJ4Y1UJG7)  
CAFFEINE (UNII: 3G6A5W338E)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
COMFREY (UNII: D05HXK6R3G)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83191-003-0370.87 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product02/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/13/2023
Labeler - Kandenwood LLC (102301802)

Revised: 12/2024
Document Id: 2a57fbd9-78d1-9dd3-e063-6394a90acc63
Set id: f49aad46-3589-18a5-e053-2995a90a75cd
Version: 2
Effective Time: 20241228
 
Kandenwood LLC