Label: SECUREMAX ANTIBACTERIAL HAND CLEANSING- ethyl alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    78092-601-01, 78092-601-02, 78092-601-03, 78092-601-04, view more
    78092-601-05, 78092-601-06, 78092-601-07, 78092-601-08, 78092-601-09, 78092-601-10, 78092-601-11, 78092-601-12, 78092-601-13, 78092-601-14, 78092-601-15, 78092-601-16
  • Packager: ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI
  • 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 26, 2020

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

  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 64.5%

    Be sure to read the label before use.

  • Purpose

    Antiseptic

  • Use

    • To decrease bacteria on the skin and clean hands.
    • Recommended for repeated use.
  • Warnings

    For external use only. Flammable, Keep away from fire or flame. Do store above 40°C.

    Do not get into eyes.

    If contact occurs, rinse thoroughly with water.

    Discontinue use

    If irritation or redness develops. If irritation persists for more than 72 hours, consult a doctor.

    Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Apply to hands until thoroughly wet.
    • Rub vigorously until dry.
    • Supervise children in the use of this product.
  • Inactive Substances and amounts (W/W): 34,25% Deionised Water, 0,75% Glycerin, 0,25% Carbomer, 0,25% Triethanolamine.

  • SPL UNCLASSIFIED SECTION

    KILLS 99,9% OF BACTERIA* /RINSE-FREE /WITH MOISTURIZER /70 ETHANOL

    SECUREMAX Antibacterial hand cleansing gel has been developed especially to ensure effective protection of the hands against tested bacteria. It kills 99.9% of the tested bacteria (*). It has been proven to provide antibacterial protection against the microorganisms listed below (*).

    (*) Bacteria type tested under laboratory conditions

    Bacteria Type: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus hirae.

    Application Area and Usage: General Area-Hand and Skin. At least 3 ml solution is applied to the hand without dilution and rubbed until the hands are dry for 60 seconds. It is not necessary to rinse.

    Application Dose: Ready to Use.

    Application Range: It is used as often as desired.

    Poisoning Symptoms: None.

    Ethyl Alcohol: LD50: (Acute oral-rat): 6200 mg/kg. (Acute dermal rabbit): 7060 mg/kg

    Antidote and necessary information: There is no specific antidote known. Toxic for bees. It can be poisonous to fish and aquatic organisms.

    First Aid Measures:

    If inhaled: Remove patient to fresh air. If you feel unwell, consult a doctor. If Swallowed: Rinse mouth with plenty of water and consult a doctor. In case of Eye Contact: If contact lenses are present, before washing the eyes, they should be removed. Open the eyelids and wash the eyes immediately with plenty of water. If the discomfort continues, consult a doctor. Hazard Statements and Descriptions: H225 Highly flammable liquid and vapour. H319 Causes serious eye irritation. Precautionary statements and Descriptions: P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233: Keep container tightly closed. P240: Ground/bond container and receiving equipment. P241: Use explosion-proof electrical/ventilating/lighting/.../equipment. P303+361+353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/ shower. P305+351+338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do - continue rinsing. P370+378: In case of fire: Use suitable fire extinguisher to extinguis​h. P337+313: If eye irritation persists get medical advice/attention. P403+235: Store in a well ventilated place. Keep cool. P501: Dispose of contents/container to in accordance with regional regulation. Keep away from children, food and animal feeds. Do not inhale vapors or particles. Do not eat or drink anything during application. Do not smoke. Store in the original packaging at a temperature below 30 °C. Keep away from sunlight. Follow the instructions for use to avoid risks on human and environmental health. Use the opened product within 6 months. The shelf life of the product is 2 years under suitable storage conditions.

    ATTENTION USED EXTERNALLY, NOT DRINKING.

    Production Date:27/04/2020

    Expiry Date:27/04/2020

    ATOMİZER KOZMETİK TURİZM VE YAPI SAN. TİC. A.Ş.

    Esenevler Mah. Korupark Sok. No:1 Ümraniye/İstanbul, Turkey www.atomizer.com.tr

    MADE IN TURKEY

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SECUREMAX  ANTIBACTERIAL HAND CLEANSING
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78092-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL64.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78092-601-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    2NDC:78092-601-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    3NDC:78092-601-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    4NDC:78092-601-04120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    5NDC:78092-601-05250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    6NDC:78092-601-06300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    7NDC:78092-601-07400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    8NDC:78092-601-08500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    9NDC:78092-601-09700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    10NDC:78092-601-10750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    11NDC:78092-601-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    12NDC:78092-601-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2020
    13NDC:78092-601-135000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/26/2020
    14NDC:78092-601-1410000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/26/2020
    15NDC:78092-601-1525000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/26/2020
    16NDC:78092-601-1630000 mL in 1 CONTAINER; Type 0: Not a Combination Product05/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/26/2020
    Labeler - ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI (364761135)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI364761135manufacture(78092-601)