Label: ASSURED MEDICATED BODY POWDER- menthol powder

  • 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 29, 2017

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

  • Active Ingredient

    Menthol 0.15%

  • Purpose

    External Analgesic

  • Uses

    Temporary relief of pain and itch associate with:

    • minor cuts
    • sunburn
    • insect bites
    • scrapes
    • minor burns
    • minor skin irritations
  • Warning

    • For external use only
    • Avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within few days

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact a poison control center right away.

  • Directions

    • adults and children 2 years and older - apply freely upto 3 or 4 times daily
    • children under 2 years - ask a doctor
    • For best results, dry skin throughly before applying
  • Inactive ingredients

    talc, zinc oxide, eucalyptol, methyl salicylate, salicylic acid, thymol, zinc stearate.

  • Warning

    This product contains talcum powder and is intended for external use only. Frequent application of talcum powder in the female genital area may increase the risk of ovarian cancer

  • PRINCIPAL DISPLAY PANEL

    NDC 42669-206-01

    ASSURED MEDICATED BODY POWDER

    TRIPLE RELIEF FORMULA

    • Absorbs Moisture
    • Relieves Itching
    • Cools Skin

    Net wt 10oz (283 g)

    Label

  • INGREDIENTS AND APPEARANCE
    ASSURED MEDICATED BODY POWDER 
    menthol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42669-206-01283 g in 1 BOTTLE; Type 0: Not a Combination Product11/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/29/2017
    Labeler - Davion, Inc (174542928)
    Registrant - Davion, Inc (174542928)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davion, Inc174542928manufacture(42669-206)