Label: LEVEL SELECT MENTHOL CAMPHOR ROLL ON- 10% menthol, 5% camphor roll on gel gel
- NDC Code(s): 83191-003-03
- Packager: Kandenwood LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2024
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- OTC-ACTIVE INGREDIENTS
- OTC-PURPOSE
- Uses
- Warnings
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When using this product:
- 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 appliation 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
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Directions:
Adults and Children 12 years and older:
- Apply a thin layer of gel to affected area no more than 3-4 times daily
- Allow gel to absorb before covering area
- Wash hands, if used, after appliation with soap and water
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Children under 12 years of age:
- Consult a physician before use
- Other Information:
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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
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INGREDIENTS AND APPEARANCE
LEVEL SELECT MENTHOL CAMPHOR ROLL ON
10% menthol, 5% camphor roll on gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83191-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83191-003-03 70.87 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 02/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 02/13/2023 Labeler - Kandenwood LLC (102301802)