Hygieni-Klean Hand Sanitizer Fluid Healthcare Grade Lavender: Package Insert and Label Information

HYGIENI-KLEAN HAND SANITIZER FLUID HEALTHCARE GRADE LAVENDER- isopropyl alcohol liquid
Custom Chemical Services, 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 Ingredients

Isopropanol 80% v/v

Purpose

Antibacterial

Uses Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

Warning Flammable. Keep away from fire or flame. For external use only.

When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, flush eyes with water immediately. Avoid contact with broken skin. Discontinue use if irritation or redness develops. If condition persists, consult a doctor.

Keep out of reach of children. Children should only use this product under adult supervison. Do not drink. Not edible. In case of accidential ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other Information Store under 105°F.

Directions Place hand sanitizer in your palm, thoroughly cover hands, including between fingers, under fingernails, and around wrists. Rub briskly until dry. No rinsing required.

Inactive Ingredients Purified water, Glycerin USP, PEG-600, Fragrance

HYGIENI-KLEAN HAND SANITIZER FLUID HEALTHCARE GRADE LAVENDER ipa liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78174-036 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 80.0691 L in 100 L

Inactive Ingredients Ingredient Name Strength GLYCERIN 0.0661 L in 100 L water 19.7435 L in 100 L POLYETHYLENE GLYCOL 600 0.0405 in 100 L FRAGRANCE LAVENDER ORC1800979 0.0808 in 100 L

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:78174-036-01 3.78541 L in 1 JUG None 2 NDC:78174-036-02 0.946353 L in 1 BOTTLE None 3 NDC:78174-036-03 0.473176 L in 1 BOTTLE None 4 NDC:78174-036-04 0.354882 L in 1 BOTTLE None 5 NDC:78174-036-05 0.236588 L in 1 BOTTLE None 6 NDC:78174-036-06 0.118294 L in 1 BOTTLE None 7 NDC:78174-036-07 0.0591471 L in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/09/2021

Labeler — Custom Chemical Services, LLC (078305908)

Establishment
Name	Address	ID/FEI	Operations
Custom Chemical Services, LLC		078305908	manufacture (78174-036)

Revised: 01/2021 Custom Chemical Services, LLC