Label: ULTIMA DET ANTISEPTIC- chloroxylenol liquid

  • 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 May 21, 2020

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

View All Sections
  • Drug Facts

  • PURPOSE

    Purpose: Antiseptic

  • ACTIVE INGREDIENTS

    Component

    Chloroxylenol - 5 %

  • INACTIVE INGREDIENTS

    Isopropyl alcohol, Castor oil, Pine oil, Lauryl alcohol ethoxylate, Methyl ester sulfonate, Water, Caramel colour E150d

  • INDICATIONS & USAGE

    Use: This product is a specially formulated hand wash soap for hygiene hand washing to decrease microbes on the skin. This concentrated antiseptic hand wash liquid should be diluted with water (1:5 ml) before use.

  • DOSAGE & ADMINISTRATION

    Directions: Wet hand with fresh water and apply soap. Rub hand together for 20 sec. Rinse hands thoroughly with fresh water.

  • WARNINGS

    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 occurs, please consult a doctor.

    Do not use

    • In children less than 2 months of age.

    • On open skin wounds.

    Warning

    • For external use only

    • Keep out of Reach of Children

  • Other information

    • Store between 15-30°C (59-86F)

    • Avoid freezing and excessive heat above 50°C (104F)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Atlantic Care Chemicals. Pvt. Ltd
    Industrial Development Plot,
    Alappuzha, Kerala, India.

    9001:2015

    ISO CERTIFIED COMPANY

    PASSION FOR INNOVATION

    care@atlanticchemicals.com
    www.atlanticchemicals.com

    MADE IN INDIA

  • Packaging

    Ultma1

  • INGREDIENTS AND APPEARANCE
    ULTIMA DET ANTISEPTIC 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77249-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL50 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WHITE PINE OIL (UNII: HA5CX6676U)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    S-METHYL METHANETHIOSULFONATE (UNII: 0906Z2356U)  
    WATER (UNII: 059QF0KO0R)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77249-107-455 L in 1 CAN; Type 0: Not a Combination Product05/15/2020
    2NDC:77249-107-010.1 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:77249-107-020.2 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    4NDC:77249-107-050.5 L in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2020
    Labeler - ATLANTIC CARE CHEMICALS PRIVATE LIMITED (861499902)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC CARE CHEMICALS PRIVATE LIMITED861499902manufacture(77249-107)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!