TOPICAL ANALGESIC- methyl salicylate ointment 
Dermaline USA Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dermaline Arnica

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

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

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

Inactive ingredients

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

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 label2.5oz

TOPICAL ANALGESIC 
methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82165-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82165-100-0270 g in 1 JAR; Type 0: Not a Combination Product05/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/15/2021
Labeler - Dermaline USA Corp (016069241)

Revised: 3/2023
Document Id: f6016fc7-5c00-0a67-e053-2995a90a0ce1
Set id: c9b6fc8a-06f9-50a9-e053-2995a90a48e8
Version: 2
Effective Time: 20230303
 
Dermaline USA Corp