Label: KEY DERMOLAC- jabon antiseptico a base de acido lactico liquid

  • NDC Code(s): 58345-105-01, 58345-105-02, 58345-105-03
  • Packager: Key Química S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 1, 2024

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  • Active ingredients

    - L-(+)-lactic acid 1.6 %

  • Purpose

    Antiseptic

  • Do not use

    Do not use this product in or near the eyes.

  • STOP USE

    Stop use if irritation or redness develop. If conditions persist for more than 72 hours, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek inmediate medical attention or call a poison center.

  • Inactive ingredients

    - Water

    - Sodium Laureth Sulfate

    - Sodium chloride

    - Cocamidopropyl betaine

    - Sodium hydroxide

    - Tetrasodium EDTA

    - Acid Red 14

    - Direct Red 81

  • Directions

    Wet hands thoroughly with product ant rise at the end.

  • Use

    To decrease bacteria on skin that could cause diseases.

  • Warnings

    - For external use only.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    KEY DERMOLAC 
    jabon antiseptico a base de acido lactico liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58345-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L-1.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DIRECT RED 81 (UNII: 7E49Q56PNB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CARMOISINE (UNII: DR4641L47F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58345-105-013 in 1 BOX07/02/2024
    1800 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:58345-105-024 in 1 BOX07/02/2024
    24000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58345-105-034 in 1 BOX07/02/2024
    34000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/02/2024
    Labeler - Key Química S.A. de C.V. (810740548)
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