LEMONGRASS ANTIMICROBIAL- benzalkonium chloride liquid
Sanit Technologies 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

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin.

Warnings

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

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Pump onto dry skin. Lather vigorously for 15 seconds. Rinse and dry.

Inactive ingredients

Water, cocamidopropyl betaine, glycerin, cetrimonium chloride, benzyl alcohol, disodium EDTA, fragrance, benzoic acid, sorbic acid, citric acid, Yellow 5 (CI 19140), sodium chloride.

Product label

image description

LEMONGRASS ANTIMICROBIAL
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71120-118
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71120-118-01	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2021	08/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/09/2021	08/31/2022

Labeler - Sanit Technologies LLC (075711022)

Name	Address	ID/FEI	Business Operations
Establishment
Sanit Technologies LLC dba Durisan		075711022	manufacture(71120-118)

Revised: 8/2021

Document Id: cadfd26a-72eb-0920-e053-2995a90a04ea

Set id: 347eedf9-97b6-4f68-a6ee-0e322804d062

Version: 2

Effective Time: 20210831

Sanit Technologies LLC