TOPICAL ANALGESIC- dermaline 3 in 1 roll on emulsion 
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 3 in1 Roll On

LabelMethyl Salicylate 15%

Topical Analgesic

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

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 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.

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.

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

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

Keep out of reach of children

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.

Arnica Roll On Label

TOPICAL ANALGESIC 
dermaline 3 in 1 roll on emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82165-107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82165-107-0385.05 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2022
Labeler - Dermaline USA Corp (016069241)

Revised: 4/2022
Document Id: dd9432cf-9398-6a97-e053-2a95a90acfce
Set id: dd9432cf-9397-6a97-e053-2a95a90acfce
Version: 1
Effective Time: 20220426
 
Dermaline USA Corp