TOPICAL ANALGESIC- dermaline 3 in 1 roll on emulsion

Topical Analgesic by

Drug Labeling and Warnings

Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Dermaline USA Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Methyl Salicylate 15%

PURPOSE

Topical Analgesic

INSTRUCTIONS FOR USE

Uses: For temporary relief of minor aches and pains of muscles and joints, such as simple backahe, lumbago, arthritis, neuralgia, strains, bruises, and sprains

WARNINGS

Warning: External use only. Keep out of reach of children. Avoid direct contact with eyes. In case of eye contact, flush thoroughly with water. Discontinue use if irritation occurs.

DO NOT USE

Do not use on wounds or damaged skin, with a bandage, with heating pad, over extensive areas of the body, on children under 16 years of age unless directed by a doctor. If pregnant or breast-feeding ask a health professional before use. In case of accidental ingestion, get medical help or contact a Poison Control center immediately.

INDICATIONS & USAGE

Directions: Adult and children 16 years and older. Wash affected area with mild soap and warm water and rinse throughly. Apply a small amount of Dermaline Arnica Ointment to the affected area 1 to 3 times daily.

INACTIVE INGREDIENT

Camphor, Capsicum Extract, Carbomer, Deionized Water, DMDM hydantoin, Eucalyptus Oil, Isopropyl Alcohol, Menthol, Polysorbate 20, Propyleneglycol, Tocopherol Acetate, Triethanolamine, Tea Tree Oil

OTHER SAFETY INFORMATION

Store at room temperature. 15 - 30 degrees C (59-86 degrees F). Avoid excessive heat & humidity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions: Adult and children 16 years and older. Wash affected area with mild soap and warm water and rinse throughly. Apply a small amount of Dermaline Arnica Ointment to the affected area 1 to 3 times daily.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPICAL ANALGESIC 
dermaline 3 in 1 roll on emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82165-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHANOLAMINE MYRISTATE (UNII: 68B0CQC306)
TEA TREE OIL (UNII: VIF565UC2G)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CARBOMER 940 (UNII: 4Q93RCW27E)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPSICUM OLEORESIN (UNII: UW86K581WY)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82165-107-03	85.05 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/15/2022

Labeler - Dermaline USA Corp (016069241)