Label: TOPICAL ANALGESIC- dermaline arnica menthol gel gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 14, 2023

If you are a consumer or patient please visit this version.

  • 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

    • on children under 16 years of age except on the advice of a physician.
  • WHEN USING

    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

    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

    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

    • Store between 15-30C (59-86F)
    • Do not expose to excessive heat.
  • 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

  • INGREDIENTS AND APPEARANCE
    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)