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 more78092-601-05, 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
- DIRECTIONS
-
SPL UNCLASSIFIED SECTION
KILLS 99,9% OF BACTERIA* /RINSE-FREE /WITH MOISTURIZER /70 0 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 extinguish. 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
-
INGREDIENTS AND APPEARANCE
SECUREMAX ANTIBACTERIAL HAND CLEANSING
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78092-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 64.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78092-601-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 2 NDC:78092-601-02 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 3 NDC:78092-601-03 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 4 NDC:78092-601-04 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 5 NDC:78092-601-05 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 6 NDC:78092-601-06 300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 7 NDC:78092-601-07 400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 8 NDC:78092-601-08 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 9 NDC:78092-601-09 700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 10 NDC:78092-601-10 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 11 NDC:78092-601-11 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 12 NDC:78092-601-12 1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/26/2020 13 NDC:78092-601-13 5000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/26/2020 14 NDC:78092-601-14 10000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/26/2020 15 NDC:78092-601-15 25000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/26/2020 16 NDC:78092-601-16 30000 mL in 1 CONTAINER; Type 0: Not a Combination Product 05/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/26/2020 Labeler - ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI (364761135) Establishment Name Address ID/FEI Business Operations ATOMIZER KOZMETIK TURIZM VE YAPI SANAYI TICARET ANONIM SIRKETI 364761135 manufacture(78092-601)