Label: APEAZ ULTRA (camphor- synthetic, menthol, and methyl salicylate cream cream

  • NDC Code(s): 57483-101-01
  • Packager: Innovus Pharmaceuticals, Inc.
  • 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 January 27, 2023

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  • Active ingredient

    Camphor 4%

    Menthol 7.5%

    Methyl Salicylate 10%

  • Purpose

    Topical analgesic

  • Uses

    For the 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 wounds or damaged, broken or irritated skin
    • with a heating pad
  • When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

  • Stop use and ask a doctor

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Center immediately

  • Directions

    • use only as directed
    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • Other information

    Store at 20° to 25°C (68° to 77°F)

    Do not purchase if outer seal is broken

  • Inactive ingredients

    carbomer, cetearyl alcohol, water, FD&C Blue no 1, FD&C Yellow no 5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane, methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    APEAZ ULTRA 
    camphor (synthetic), menthol, and methyl salicylate cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-101
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.0 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57483-101-011 in 1 CARTON02/05/2018
    156.7 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/05/2018
    Labeler - Innovus Pharmaceuticals, Inc. (962507187)
    Registrant - Innovus Pharmaceuticals, Inc. (962507187)
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