FDA.reportPublic FDA data

DolFrost Cool and Soothing Roll-On

Manufacturer
Dermatech Laboratories LLC
Effective date
2017-02-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:20:13

Label at a glance#

ProductDolFrost Cool and Soothing Roll-On
Active ingredientMENTHOL
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

Menthol 2.00%

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 .

• 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast feeding, contact physician prior to use.

Allergy Alert:

SPL UNCLASSIFIED SECTION

If you have had a prior allergic reaction to aspirin or salicylates, please consult 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

Arnica Montana (Arnica) Extract, Aqua (Deionized Water), Carbomer, Camphor, Dimethyl Sulfone, Methyl Paraben, Methyl Salicylate, Polysorbate 20, Propyl Paraben, Rosmarinus Officinalis (Rosemary) Leaf Extract, Triethanolamine.

​Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NewLabelNewLabel

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70899-75570899-755-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWIACT
WATER059QF0KO0RIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
METHYLPARABENA2I8C7HI9TIACT
METHYL SALICYLATELAV5U5022YIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLPARABENZ8IX2SC1OHIACT
ROSEMARYIJ67X351P9IACT
TROLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AACTIB

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
0722aef3-17ad-f15d-e063-6394a90a4f8bbf4001ed-9a42-4236-a4a5-6be9180bd35c2023-10-07WarningsExact identifier
spl set id: bf4001ed-9a42-4236-a4a5-6be9180bd35c

Reported adverse events (FAERS/openFDA)#

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