Label: DR.HEAL ALCOHOL PADS- alcohol cloth

  • NDC Code(s): 78031-401-01
  • Packager: Shenzhen Lvyan Technology Co., Ltd.
  • 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 June 3, 2020

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

  • SPL UNCLASSIFIED SECTION

    Dr.Heal Alcohol Pads

  • Active Ingredient(s)

    ALCOHOL 3g/pcs. Purpose: Antiseptic

  • Purpose

    Antiseptic, Dr.Heal Alcohol Pads

  • Use

    Dr.Heal Alcohol Pads 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

    • Tear open packet. Unfold and apply wipe thoroughly onto hands or surfaces.
    • Discard after single use. No rinsing required.
    • Dispose of used wipes in trash receptacle. Do not flsuh.
    • 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

    purified water USP

  • Package Label - Principal Display Panel

    1115

  • INGREDIENTS AND APPEARANCE
    DR.HEAL ALCOHOL PADS 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78031-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78031-401-011 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Shenzhen Lvyan Technology Co., Ltd. (549643707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Lvyan Technology Co., Ltd.549643707manufacture(78031-401)