SPL v2
SPL
SPL Set ID bd9c08ba-9e19-4c2e-e053-2a95a90aadd6
Route
TOPICAL
Published
Effective Date 2021-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.18 mg)
Inactive Ingredients
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Medium-chain Triglycerides Stearyl Alcohol Lavender Oil Glycerin Sunflower Oil Tri-n-butyl Phosphate Stearic Acid Zinc Oxide Alcohol Water Polysorbate 60 Soybean Oil Octoxynol-1 Isohexadecane Glyceryl Monostearate Aloe Vera Leaf Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-22

Description

DRUG FACTS

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

DRUG FACTS

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

For external uses only

Directions

Apply half an inch each morning on clean skin

Drug Facts

DRUG FACTS

Purpose Section

Antimicrobial

Active Ingredients

Benzalkonium Chloride, 0.18%

When Using Section

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

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

Stop Use and Ask A Doctor

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

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

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.


Structured Label Content

Uses (USES)
  • to help reduce germs on the skin
  • Recommended use once a day or as needed
Warnings (WARNINGS)

For external uses only

Directions (DIRECTIONS)

Apply half an inch each morning on clean skin

Drug Facts (DRUG FACTS)

DRUG FACTS

Purpose Section (PURPOSE SECTION)

Antimicrobial

Active Ingredients (ACTIVE INGREDIENTS)

Benzalkonium Chloride, 0.18%

When Using Section (WHEN USING SECTION)

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

Inactive Ingredients (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

Stop Use and Ask A Doctor (STOP USE AND ASK A DOCTOR)

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

Principal Display Panel 89 Ml (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

Keep Out of Reach of Children Section (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)