Label: ASPERFLEX ORIGINAL MAXIMUM STRENGTH- menthol patch

  • 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 12, 2023

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  • DRUG FACTS

  • Active Ingredient

    Menthol 7.5%

  • Purpose

    Topical analgesic

  • Uses

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

    ■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises

  • Warnings

    For external use only

    Do not use

    ■ on wounds, damaged, broken or irritated skin

    ■ with a heating pad or apply local heat to the area of use

    When using this product

    • use only as directed. Read and follow all directions and warnings on this carton.
    • do not allow contact with
    • the eyes and mucous membranes
    • rare cases of serious burns have been reported with products of this type
    • do not apply to wounds or damaged, broken or irritated skin
    • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
    • do not use at the same time as other topical analgesics
    • a transient burning sensation may occur upon application but generally disappears in several days
    • avoid applying into skin folds <do not use more than 4 patches at a time

    Stop use and ask a doctor if

    ■ condition worsens or symptoms persist for more than 7 days

    ■ symptoms clear up and occur again within a few days

    ■ severe burning sensation, redness or irritation develop

    ■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    adults and children 12 years of age and older:

    ■ gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.

    ■ remove remaining film backing from both sides and finish applying to skin

    ■ apply to affected area not more than 3 to 4 times daily

    children under 12 years of age: consult a doctor

  • Other Information

    store at room temperature 15°-30°C (59°-86°F).

  • Inactive ingredients

    aluminum glycinate, propylene glycol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tartaric acid, 2,4-Imidazolidinedione, disodium edta, water, glycerin

  • Questions or Comments?

    Call toll-free 1-877-255-6999.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    ASPERFLEX ORIGINAL MAXIMUM STRENGTH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-4461
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL210 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    TARTARIC ACID (UNII: W4888I119H)  
    HYDANTOIN (UNII: I6208298TA)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-4461-55 in 1 CARTON11/04/2021
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/04/2021
    Labeler - Akron Pharma Inc. (067878881)
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