FDA.reportPublic FDA data

KELVIN PRO Pain Relief Roll On

Manufacturer
US Cosmetics, Inc
Effective date
2018-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:43:50

Label at a glance#

ProductKELVIN PRO Pain Relief Roll On
Active ingredientMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)
Label structure7 sections

Dosage and administration

Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 12%

Camphor 3%

Purpose:

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

Warnings:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.

Do not apply

OTC - DO NOT USE SECTION

  • to open wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

Additional Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72569-76072569-760-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TROLAMINE9O3K93S3TKIACT
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

Source Document#

Source XML · Source PDF

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
0724525a-b474-0160-e063-6394a90ac7a29cb6dfd1-c655-46dc-b4d4-5c2b8a2e42aa2023-10-07WarningsExact identifier
spl set id: 9cb6dfd1-c655-46dc-b4d4-5c2b8a2e42aa

Reported adverse events (FAERS/openFDA)#

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