Label: REDICARE ANTISEPTIC WIPES- antiseptic wipes swab

  • 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 October 29, 2019

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  • Active Ingredient

    Ethyl Alcohol 66.5%

    Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on skin whenever soap and water are not readily available
  • WARNINGS

    For external use only.

    Flammable, keep away from fire or flame

    Do not use

    in the eyes. If this happens, rinse thoroughly with water.

    Stop use and ask a doctor if

    • irritation or redness develops and persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Tear open packet, remove towelette
    • wet hands and wrists thoroughly for 15 seconds and discard
    • supervise children under 6 years of age
  • Inactive ingredients

    Aloe vera, fragrance, purified water, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    Packet

  • INGREDIENTS AND APPEARANCE
    REDICARE ANTISEPTIC WIPES 
    antiseptic wipes swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL665 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-311-2525 in 1 BOX10/29/2019
    1NDC:71105-311-010.0019 L in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/29/2019
    Labeler - Redicare LLC (800149346)
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