Label: AA TOP MEDICATED- menthol and methyl salicylate oil

  • 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 12, 2018

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  • Drug Facts

  • Active Ingredients

    Menthol 10%

    Methyl Salicylate 5%

  • Purpose

    External analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external Use Only

    Do not use

    • on wounds
    • on irritated or damaged skin
    • otherwise than as directed

    When using this product

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

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 or 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations.
    • children under 12 years of age: consult your physician.
    • refer to the above warnings; use otherwise than directed may be dangerous.
  • Other information

    • store at 16° to 30°C (61° to 86°F)
    • store in an airtight container
  • Inactive Ingredients

    Saposhnikoviae Radix, Artemisia Argyi Leaf, Moutan Cortex, Carpesii Fructus, Cimicifugae Rhizoma, Sophorae Flavescentis Radix, Impatiens Balsamina, Paeoniae Rubra Radix, Zanthoxyli Pericarpium, Glycyrrhizae Radix Et Rhizoma, Ocimum Basilicum, Notoginseng Radix Et Rhizoma, Carthami Flos, Ethyl Alcohol

  • Principal Display Panel

    A&A Top Medicated Oil

    external analgesic

    1.75FL OZ. (50mL)

    Distributed By:

    A&A Medical Supplies, Inc.

    S. El Monte, CA 91733 USA

    Made in Taiwan

    PDP

  • INGREDIENTS AND APPEARANCE
    AA TOP MEDICATED 
    menthol and methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68233-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    IMPATIENS BALSAMINA WHOLE (UNII: ZMK32KX641)  
    LICORICE (UNII: 61ZBX54883)  
    OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    SAPOSHNIKOVIA DIVARICATA WHOLE (UNII: LA61LWB4JH)  
    PAEONIA X SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)  
    ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)  
    PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U)  
    PAEONIA LACTIFLORA WHOLE (UNII: N44H57P7WG)  
    ALCOHOL (UNII: 3K9958V90M)  
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
    CARPESIUM ABROTANOIDES FRUIT (UNII: 20C78R73NH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68233-810-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2018
    Labeler - Albert Max, Inc. (149445798)
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