Label: ASPERFLEX HOT- camphor, menthol, methyl salicylate 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 November 20, 2021

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

  • Active ingredients

    Capsicum extract 0.025% as Capsaicin
    Menthol 1.25%

  • Purpose

    Topical analgesic

  • Uses

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

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

    For external use only

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor if

    • rash, itching or excessive skin irritation develops
    • contisions worsen
    • symptoms persist for more than 7 days
    • symptoms 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.

    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 over:

    • clean and dry affected area
    • remove patch from film
    • apply to affected area not more than 3 to 4 times daily
    • remove patch from the skin after at most 8-hour application

    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.

    Manufactured for:
    Akron Pharma, Inc.
    Fairfield, NJ 07004

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    crtn

  • INGREDIENTS AND APPEARANCE
    ASPERFLEX HOT 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-4439
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM0.025 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    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:71399-4439-66 in 1 BOX11/04/2021
    17 g 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)