HAND SHIELD 24 HAND SANITIZER by CLEAR LAKE RESEARCH, LLC / Clear Lake Research, LLC

Drug Details [pdf]

HAND SHIELD 24 HAND SANITIZER- 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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Active Ingredient

ACTIVE INGREDIENT

Benzalkonium Chloride 0.18%

Purpose section

Antimicrobial

Warnings

For external uses only

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

to help reduce germs on the skin
Recommended use once a day or as needed

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

Hand Shield 24

HAND SHIELD 24 HAND SANITIZER
benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81495-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.18 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 60 (UNII: CAL22UVI4M)	0.848 mL in 100 mL
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)	0.954 mL in 100 mL
ISOHEXADECANE (UNII: 918X1OUF1E)	0.848 mL in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.01 mL in 100 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	5.5 mL in 100 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	0.5 mL in 100 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.5 mL in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z)	3 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL in 100 mL
OCTOXYNOL-1 (UNII: 20CAX7IO75)	0.99 mL in 100 mL
ALCOHOL (UNII: 3K9958V90M)	0.009 mL in 100 mL
SOYBEAN OIL (UNII: 241ATL177A)	8 mL in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.42 mL in 100 mL
SUNFLOWER OIL (UNII: 3W1JG795YI)	7 mL in 100 mL
TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5)	1 mL in 100 mL
WATER (UNII: 059QF0KO0R)	61.3382 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	7.5 mL in 100 mL
STEARIC ACID (UNII: 4ELV7Z65AP)	0.5 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81495-111-03	88.7 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2021	03/23/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/01/2021	03/23/2021

Labeler - CLEAR LAKE RESEARCH, LLC (077493647)

Name	Address	ID/FEI	Business Operations
Establishment
Clear Lake Research, LLC		077493647	label(81495-111)

Revised: 12/2021

Document Id: d4630fa2-47c7-65c2-e053-2a95a90aa9c3

Set id: ba5f4750-6c29-4369-e053-2a95a90a9a94

Version: 4

Effective Time: 20211230