ISSENGARD 24 HAND SANITIZER 3 OZ- benzalkonium chloride cream 
Clear Lake Research, LLC

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.

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DRUG FACTS

DRUG FACTS

ACTIVE INGREDIENTS

Benzalkonium Chloride, 0.18%

PURPOSE SECTION

Antimicrobial

WARNINGS

For external uses only

USES

WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

STOP USE AND ASK A DOCTOR

Stop use and ask a doctor if rash, irritation, or other allergic reaction occurs

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children, if the product is swallowed, get medical help or contact a Poison Center right away.

DIRECTIONS

Apply half an inch each morning on clean skin

INACTIVE INGREDIENTS

Water (Aqua), Glycine soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Tributyl Phosphate, Glycerin, t-Octylphenoxy-polyethoxyethanol, Hydroxy- ethylacrylate/Sodium Acryloyldimethyl Taurate, Copolymer, Isohexadecane, Polysorbate 60, Glyceryl Stearate, Stearic Acid, Stearyl Alcohol, Lavandula angustifolia (Lavender) Oil, Propylene Glycol, Ethyl Alcohol, Zinc Oxide CI 77947

PRINCIPAL DISPLAY PANEL - 89 mL

Issengard 24

Non-alcohol HAND SANITIZER

with Invisible Shield Technology

Kills > 99.99% of Germs

3 FL OZ / 89 mL

Made in USA

Product by: Clear Lake Research, LLC

www.issengard.com

Issengard 24 3 oz

ISSENGARD 24 HAND SANITIZER 3 OZ 
benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81495-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.18 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SOYBEAN OIL (UNII: 241ATL177A)  
OCTOXYNOL-1 (UNII: 20CAX7IO75)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81495-112-0389 mL in 1 TUBE; Type 0: Not a Combination Product03/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/22/2021
Labeler - Clear Lake Research, LLC (077493647)
Establishment
NameAddressID/FEIBusiness Operations
Columbia Cosmetic Manufacturing, Inc068267863manufacture(81495-112)
Establishment
NameAddressID/FEIBusiness Operations
Clear Lake Research, LLC077493647label(81495-112)

Revised: 12/2021
Document Id: d4631a16-1d99-bc80-e053-2995a90a242b
Set id: bd9c08ba-9e19-4c2e-e053-2a95a90aadd6
Version: 2
Effective Time: 20211230
 
Clear Lake Research, LLC