Label: ABUTOL ANTISEPTIC HAND WASH OLIVE OIL AND ROSEMARY- benzalkonium chloride liquid

  • 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 November 2, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.12%

  • Purpose

    Antiseptic

  • Uses

    • for handwashing to decrease bacteria on the skin

    • recommended for repeated use

  • Warnings

    For external use only

    Do not use

    • in children less than 2 months of age

    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop

    • condition 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

    • wet hands and forearms. Apply 5 millilitre (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds

    • rinse and repeat

    • supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    • store between 15-30°C (59-86°F)

    • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    water (aqua),benzophenone-4, citric acid, cocamide DEA, cocamidopropyl betaine, DMDM hydantoin, D&C Orange No. 4 , FD&C Blue No.1, glycerin, methylchloroisothiazolinone, methylisothiazolinone, fragrance, sodium chloride, sodium laureth sulfate, tetrasodium EDTA

  • SPL UNCLASSIFIED SECTION

    with Moisturizer 

    Olive Oil & Rosemary

    - Cleans and softens hands

    Distributed by:

    American Brands and More LLC, Wood Ridge, NJ 07075

    Made in TURKEY

    You may also report any serious side effects to

    PO Box 328, Wood Ridge,

    NJ 07075-328

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    ABUTOL ANTISEPTIC HAND WASH OLIVE OIL AND ROSEMARY 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77418-201-20500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/03/2020
    Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI566218248manufacture(77418-201)
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