TOPICAL ANALGESIC- dermaline arnica 3 in 1 ointment

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(s)

Methyl Salicylate 15% . Purpose: Topical Analgesic

Purpose

Topical Analgesic

Use

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

Warnings

For external use only. Avoid Contact with the eyes. Do not bandage tightly or apply to wounds or damaged costs.

Do not use

• On children under 16 years of age except on the advice of the physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PREGNANCY

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case accidental ingestion, get medical help or contact a Poision Control Center right away.

Directions

Adults and children 16 years of age and older: Wash the affected area with mild soap and warm water and rinse thoroughly. Apply to affected area not more than 3 to 4 times daily.

Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age; consult a doctor.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat

Inactive ingredients

Arnica, camphor, eucalyptus oil, D&C brown #486. Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum

STOP USE

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days.

Package Label - Principal Display Panel

2.5oz

INGREDIENTS AND APPEARANCE

TOPICAL ANALGESIC 
dermaline arnica 3 in 1 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82165-101
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 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL (UNII: L7T10EIP3A)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
TEA TREE OIL (UNII: VIF565UC2G)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82165-101-02	70 g in 1 JAR; Type 0: Not a Combination Product	05/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/15/2021

Labeler - Dermaline USA Corp (016069241)