TOPICAL ANALGESIC- dermaline arnica salve black 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 Salve Black

Active Ingredient(s)

Dermaline LabelMethyl 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.

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 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. 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

Inactive ingredients

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

Package Label - Principal Display Panel

Label Display2.5oz

TOPICAL ANALGESIC 
dermaline arnica salve black ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82165-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE5 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorblackScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82165-102-0270 g in 1 JAR; Type 0: Not a Combination Product05/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/30/2021
Labeler - Dermaline USA Corp (016069241)

Revised: 3/2023
Document Id: f601320e-064f-9b34-e053-2a95a90ac61b
Set id: caf2318f-b320-74c6-e053-2a95a90a315d
Version: 2
Effective Time: 20230303
 
Dermaline USA Corp