Level Select Menthol Camphor Roll On

Manufacturer
Kandenwood LLC
Effective date
2024-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:28

Label at a glance#

ProductLevel Select Menthol Camphor Roll On
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure12 sections

Indications and uses

Temporary relief from minor aches and pains of muscles and joints, associated with strains, sprains,arthritis, backache, bruises

Dosage and administration

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 _______________________________________________________________ Children under 12 years of age: Consult a physician before use

Label contents#

Full prescribing information#

OTC-ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Camphor 5%

OTC-PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of muscles and joints, associated with strains, sprains,arthritis, backache, bruises

Warnings

WARNINGS SECTION

For external use only

When using this product:

OTC - WHEN USING SECTION

  • 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:

OTC - ASK DOCTOR SECTION

  • 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:

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a physician before use

Keep out of reach of chlidren and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally ingested, please seek medical help

Directions:

DOSAGE & ADMINISTRATION SECTION

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

_______________________________________________________________

Children under 12 years of age:

  • Consult a physician before use

Other Information:

OTHER SAFETY INFORMATION

Store in a cool, dry place iwth lid closed tightly

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Level Select Roll On Gel 2.5 ozLevel Select Roll On Gel 2.5 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2700387camphor 5 % / menthol 10 % Topical GelPSN2
2700387camphor 0.05 MG/MG / menthol 0.1 MG/MG Topical GelSCD2
2700387camphor 5 % / menthol 10 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83191-003-03Level Select Menthol Camphor Roll On70.87 g in 1 TUBE, WITH APPLICATORGEL70.872

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83191-003LEVEL SELECT MENTHOL CAMPHOR ROLL ON (10% MENTHOL, 5% CAMPHOR ROLL ON GEL) GEL [KANDENWOOD LLC]21 package rows20241229_f49aad46-3589-18a5-e053-2995a90a75cd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83191-00383191-003-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2a57fbd9-78d1-9dd3-e063-6394a90acc63f49aad46-3589-18a5-e053-2995a90a75cd2024-12-28WarningsExact identifier
spl id: 2a57fbd9-78d1-9dd3-e063-6394a90acc63
spl set id: f49aad46-3589-18a5-e053-2995a90a75cd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.