LEVEL SELECT MENTHOL CAMPHOR PATCH- 10% menthol, 5% camphor patch patch 
Kadenwood 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.

----------

Level Select 10% Menthol, 5% Camphor

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:

Clean the area you wish to adhere the patch to.

Remove backing from the patch

Apply the patch to the cleaned and dried area.

Apply pressure to the patch for 30 seconds, pressing firmly against the skin.

Wear one patch for up to 8 hours

Repeat as necessary, but no more than 3 times daily

Children under 12 years of age:

Other Information:

Store in a cool, dry place

Inactive Ingredients:

MSM, Beta Caryophylene, Horse Chestnut Extract, Organic Comfrey, Caffeine, Lemongrass Essential Oil, Rosemary Extract, Acrylic Adhesive, Polyethylene Foam

Level Select 10% Menthol 5% Camphor Patch

Level Select Menthol Camphor Patch

LEVEL SELECT MENTHOL CAMPHOR PATCH 
10% menthol, 5% camphor patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83191-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 100 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
CAFFEINE (UNII: 3G6A5W338E)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
COMFREY (UNII: D05HXK6R3G)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83191-004-04255 mg in 1 BOX; Type 0: Not a Combination Product01/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/19/2023
Labeler - Kadenwood LLC (102301802)
Registrant - Akron Coating & Adhesives (186569323)
Establishment
NameAddressID/FEIBusiness Operations
Akron Coating & Adhesives186569323manufacture(83191-004)

Revised: 3/2023
Document Id: f7a76b91-fc13-3866-e053-6294a90ad409
Set id: f2a125f3-8017-eb6f-e053-2995a90afd82
Version: 4
Effective Time: 20230324
 
Kadenwood LLC