TOPICAL ANALGESIC- dermaline arnica menthol gel gel 
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 Gel

Active Ingredient(s)

Menthol 1%. Purpose: Topical Analgesic

Purpose

Topical Analgesic, Gel

Use

For temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritation.

Warnings

For external use only. Flammable. Keep away from fire or flames.

Avoid Contact with eyes. Do not bandage tightly.

Do not apply over large areas of the body.

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Incase accidental ingestion, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison 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 yeats of age: consult a doctor.

Other information

Inactive ingredients

Arnica Extract, Camphor, Carbomer, Deionized Water, DMDM Hydatoin, Ethyl Alcohol, Eucalyptus Oil, Isopropyl Alcohol, Nonoxynol-9, polysorbate 20, propyleneglycol, Tea Tree Oil, Trirthanolamine.

Package Label - Principal Display Panel

Label141 g

TOPICAL ANALGESIC 
dermaline arnica menthol gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82165-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
AMMONIUM NONOXYNOL-9 SULFATE (UNII: 8Y8LQ8CRCC)  
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
TEA TREE OIL (UNII: VIF565UC2G)  
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ARNICA MONTANA (UNII: O80TY208ZW)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82165-104-05141 g in 1 JAR; Type 0: Not a Combination Product05/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/10/2021
Labeler - Dermaline USA Corp (016069241)

Revised: 2/2023
Document Id: f4aab3cb-e7eb-1f9f-e053-2a95a90ae583
Set id: d03cec22-7ac1-747c-e053-2995a90a87db
Version: 3
Effective Time: 20230214
 
Dermaline USA Corp