SUME APOTHECARY ALCOHOL FREE HAND SANITIZER LAVENDER AND WHITE SAGE- benzalkonium chloride liquid
LAB-CLEAN, INC

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

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Use

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only!

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Spray a small amount of product into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Inactive ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

Package Label - Principal Display Panel

Label

SUME APOTHECARY ALCOHOL FREE HAND SANITIZER LAVENDER AND WHITE SAGE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73126-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73126-013-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020
2	NDC:73126-013-02	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/09/2020	04/20/2024

Labeler - LAB-CLEAN, INC (199822219)

Name	Address	ID/FEI	Business Operations
Establishment
LAB-CLEAN, INC		199822219	manufacture(73126-013)

Revised: 4/2022

Document Id: dd93f845-7038-e6ad-e053-2995a90a45c7

Set id: c69fa88b-018c-4ac6-8ff5-a4de444407fc

Version: 3

Effective Time: 20220426

LAB-CLEAN, INC