Label: MYHEALTH MOOD CARE WOMEN- aluminum sesquichlorohydrate aerosol, spray

  • NDC Code(s): 80661-008-01
  • Packager: Aeroflex Industria de Aerosol Ltda
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 27, 2022

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  • Active Ingredients

    Aluminum sesquichlorohydrate 25%

  • Purpose

    Antiperspirant

  • Uses

    Reduces underarm wetness.

  • Warnings

    • FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN CAUSE SERIOUS INJURY OR DEATH.
    • Keep away from face and mouth to avoid breathing in.
    • Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F/50°C or in enclosed places that could overheat.
    • Do not use on broken skin. Stop use if rash or irritation occurs.
    • Ask a doctor before using if you have kidney disease.
    • KEEP OUT OF REACH OF CHILDREN.
    • USE ONLY AS DIRECTED. INTENTIONAL MISUSE BY DELIBERATELY CONCENTRATING AND INHALING THE CONTENTS CAN BE HARMFUL OR FATAL.
  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    For underarm use only.

  • Other Information

    Do not expose to the sun or to temperatures above 120°F/ 50°C

  • Inactive Ingredients

    butane, isobutane, propane, methylal, cyclopentasiloxane, isopropyl myristate, parfum, quaternium-18, hectorite, propylene carbonate, 2-methyl 5-cyclohexylpentanol

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    MYHEALTH MOOD CARE WOMEN 
    aluminum sesquichlorohydrate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80661-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    METHYLAL (UNII: 7H1M4G2NUE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    HECTORITE (UNII: 08X4KI73EZ)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    2-METHYL 5-CYCLOHEXYLPENTANOL (UNII: 460837ILID)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80661-008-01150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35001/01/2023
    Labeler - Aeroflex Industria de Aerosol Ltda (898397347)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aeroflex Industria de Aerosol Ltda898397347manufacture(80661-008)
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