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

Level Select Menthol Camphor Patch by

Drug Labeling and Warnings

Level Select Menthol Camphor Patch by is a Otc medication manufactured, distributed, or labeled by Kadenwood LLC, Akron Coating & Adhesives. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• Wash hands after applying and removing patch
• Avoid contact with eyes, mucous membranes, and genital areas
• Do not use on irritated, broken, or damaged skin. If redness or irritation occurs discontinue use.
• If skin is sensitive, consult a physician before use
• Do not bandage the area of application
• Do not use a heating pad with this product
• Do not use in combination with other topical products
• Do not expose applicaton site to heat or direct sunlight

Stop use and ask a doctor if:

• Condition worsens
• Symptoms continue for more than 7 days
• Symptoms clear up and then get worse
• You experience blistering, severe burning pain, or swelling at applicaton site

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:

• Consult a physician before use

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83191-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 100 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83191-004-04	255 mg in 1 BOX; Type 0: Not a Combination Product	01/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/19/2023

Labeler - Kadenwood LLC (102301802)

Registrant - Akron Coating & Adhesives (186569323)

Establishment
Name	Address	ID/FEI	Business Operations
Akron Coating & Adhesives		186569323	manufacture(83191-004)