Herbal Sage Antimicrobial by Sanit Technologies LLC / Sanit Technologies LLC dba Durisan

Herbal Sage Antimicrobial by

Drug Labeling and Warnings

Herbal Sage Antimicrobial by is a Otc medication manufactured, distributed, or labeled by Sanit Technologies LLC, Sanit Technologies LLC dba Durisan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HERBAL SAGE 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, sodium chloride , cetrimonium chloride, benzyl alcohol, disodium EDTA, fragrance, benzoic acid, sorbic acid, citric acid, blue 1 (CI 42090), yellow 5 (CI 19140), red 40 (CI 16035)

Product Label

HERBAL SAGE ANTIMICROBIAL 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71120-119
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71120-119-01	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/09/2021	08/31/2022

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

Labeler - Sanit Technologies LLC (075711022)

Establishment
Name	Address	ID/FEI	Business Operations
Sanit Technologies LLC dba Durisan		075711022	manufacture(71120-119)

Revised: 8/2021

Document Id: cadfe3c3-f431-8d15-e053-2a95a90aab46

34390-5

Set id: 906eab55-9401-467b-8cab-2486578801bd

Version: 2

Effective Time: 20210831