Label: DISINFECTANT- alcohol spray

  • Category: HUMAN OTC DRUG LABEL

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 June 16, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Disinfectant Spray

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    water

  • Package Label - Principal Display Panel

    500ml label spray500 mL NDC: 76714-002-01

    200 mL NDC: 76714-002-02 200ml spray

    500 mL NDC:76714-002-03 500 AURA

    300 mL NDC:76714-002-04 300 AURA

    360mL NDC: 76714-002-05 360 AURA

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76714-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 125 mL  in 500 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76714-002-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    2NDC:76714-002-02200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    3NDC:76714-002-03500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    4NDC:76714-002-04300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    5NDC:76714-002-05360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/30/2020
    Labeler - Guangdong Yawei Bioscience Co., Ltd  (543334955)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Yawei Bioscience Co., Ltd 543334955manufacture(76714-002)
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