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.

----------

Active Ingredient

ACTIVE INGREDIENT

Benzalkonium Chloride 0.18%

Purpose section

Antimicrobial

Warnings

For external uses only

Drug Facts

Drug Facts

When using this product

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

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

Uses

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 - 30 mL

ISSENGARD

Hand Cream Protectant

Kills > 99.99% of Germs

Non-alcohol HAND SANITIZER

1 FL OZ / 30 mL

Made in USA

Issengard 1 oz front label

Issengard 1 oz back label

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
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTOXYNOL-1 (UNII: 20CAX7IO75)  
ALCOHOL (UNII: 3K9958V90M)  
SOYBEAN OIL (UNII: 241ATL177A)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81495-112-0130 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/03/2022
Labeler - CLEAR LAKE RESEARCH, LLC (077493647)
Establishment
NameAddressID/FEIBusiness Operations
Clear Lake Research, LLC077493647label(81495-112)

Revised: 12/2022
Document Id: f0ff1932-36af-200e-e053-2a95a90a6895
Set id: d4bb96cb-c448-7193-e053-2995a90ad5d6
Version: 2
Effective Time: 20221229
 
CLEAR LAKE RESEARCH, LLC