DOLFROST COOL AND SOOTHING ROLL-ON- menthol liquid

DolFrost Cool and Soothing Roll-On by

Drug Labeling and Warnings

DolFrost Cool and Soothing Roll-On by is a Otc medication manufactured, distributed, or labeled by Dermatech Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 2.00%

Topical Analgesic

Indications:

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

Warnings

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.

If swallowed, consult physician.

Do not apply to wounds or damaged skin.
Do not bandage tightly.

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

Allergy Alert:

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

Directions

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

Store at room temperature.

Other Ingredients

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:

INGREDIENTS AND APPEARANCE

DOLFROST COOL AND SOOTHING ROLL-ON 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70899-755
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA (UNII: O80TY208ZW)
WATER (UNII: 059QF0KO0R)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ROSEMARY (UNII: IJ67X351P9)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70899-755-01	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/14/2016

Labeler - Dermatech Laboratories LLC (080300525)