TOPICAL ANALGESIC- dermaline arnica salve black 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 5% Purpose: Topical Analgesic

Purpose

Topical Analgesic, Ointment

Use

For temporary relief 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 skin.

Do not use

Do not Use on children under 16 years of age except on the advice of a physician.

WHEN USING

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.

STOP USE

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case accedental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Apply to affected area not more than 3 to 4 times daily.

Other information

• Store at controlled room temperature 15-30C (59-86F)
• Do not expose to excessive heat

Inactive ingredients

Arnica, Camphor, D&C Brown #486, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, White Petrolatum.

Package Label - Principal Display Panel

2.5oz

INGREDIENTS AND APPEARANCE

TOPICAL ANALGESIC 
dermaline arnica salve black ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82165-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	5 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
ARNICA MONTANA (UNII: O80TY208ZW)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
MENTHOL (UNII: L7T10EIP3A)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	black	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82165-102-02	70 g in 1 JAR; Type 0: Not a Combination Product	05/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/30/2021

Labeler - Dermaline USA Corp (016069241)