Label: LEVEL SELECT MENTHOL CAMPHOR PATCH- 10% menthol, 5% camphor patch patch
- NDC Code(s): 83191-004-04
- Packager: Kadenwood LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 24, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- OTC-ACTIVE INGREDIENTS
- OTC-PURPOSE
- Uses
- Warnings
-
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:
- If pregnant or breastfeeding:
- Keep out of reach of chlidren and pets
-
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:
- Inactive Ingredients:
- Level Select 10% Menthol 5% Camphor Patch
-
INGREDIENTS AND APPEARANCE
LEVEL SELECT MENTHOL CAMPHOR PATCH
10% menthol, 5% camphor patch patchProduct 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)
