LEVEL SELECT MENTHOL CAMPHOR MUSCLE RUB- 10% menthol, 5% camphor muscle rub lotion lotion 
Kandenwood LLC

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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Level Select 10% Menthol, 5% Camphor 6 ozTube

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:

Apply a thin layer of lotion to affected area no more than 3-4 times daily
Massage product into skin until fully absorbed
Wash hands, if used, after appliation with soap and water


_______________________________________________________________

Children under 12 years of age:

Consult a physician before use

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 6 oz Tube Lotion

Level Select 6 oz Lotion

LEVEL SELECT MENTHOL CAMPHOR MUSCLE RUB 
10% menthol, 5% camphor muscle rub lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83191-001
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
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
PROPANEDIOL (UNII: 5965N8W85T)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
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)  
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
C15-23 ALKANE (UNII: J3N6X3YK96)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83191-001-0170.87 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 not finalpart34802/13/2023
Labeler - Kandenwood LLC (102301802)

Revised: 3/2023
Document Id: f71ec778-e308-7fd9-e053-6394a90af31d
Set id: f52426c3-c458-6a1b-e053-2a95a90ad6cb
Version: 2
Effective Time: 20230317
 
Kandenwood LLC