Label: ANESTHALL PAIN RELIEVING CREAM- methyl salicylate, menthol cream

  • NDC Code(s): 84006-101-04
  • Packager: Advanced Pharmaceutics Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 11, 2024

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  • Active ingredients

    Menthol USP 12%

    Camphor 6%

  • Purpose

    Methyl Salicylate 6.1%..................... External Analgesic

    Menthol 4.6%....................................External Analgesic

  • Uses

    for temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • Sprains
  • Warnings

    For external use only

    Do not use

    • on damaged or broken skin

    When using this product

    • do not bandage tightly
    • avoid contact with eyes

    Stop use and ask doctor if

    • condition worses or if symptoms persist for more than 7 days, or clear up and occur again within a few days
    • redness is present
    • irritation develops

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

  • Directions

    • Adults and children 2 years of age and older:Apply to affected area not more than 4 times daily
    • Children under 2 years of age: Do Not Use
  • Other information

    • Store at 15-30C (59-86F) away from direct sunlight
  • Inactive ingredients

    Cetyl Alcohol, Dimethicone, Gentian Violet, Glyceryl Monostearate, Oil of Cajeput, Oil of Eucalyptus, Potassium Hydroxide, Propylene Glycol, Water, Sodium Borate, Sorbitan Sesquioleate, Stearic Acid, Thymol.

  • PRINCIPAL DISPLAY PANEL

    Anesthall 4 oz

    Anesthall

    Pain Relieving Cream

    Methyl Salicylate 6.1%

    Menthol 4.6%

    For temporary relief of minor aches and pains

    Net Wt. 4 oz (113.5 g)

  • INGREDIENTS AND APPEARANCE
    ANESTHALL PAIN RELIEVING CREAM 
    methyl salicylate, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84006-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON (UNII: Z4152N8IUI)  
    GENTIAN VIOLET (UNII: J4Z741D6O5)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    THYMOL (UNII: 3J50XA376E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MELALEUCA VIRIDIFLORA FLOWERING TOP (UNII: GC065MH3T2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84006-101-04113.5 g in 1 TUBE; Type 0: Not a Combination Product01/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/11/2023
    Labeler - Advanced Pharmaceutics Inc (926612636)
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