MEDISEPTIC ANTIINFECTANT by PORTOFINO & ASSOCIATES, LLC MEDISEPTIC ANTIINFECTANT

Drug Details [pdf]

MEDISEPTIC ANTIINFECTANT- benzalkonium chloride liquid
PORTOFINO & ASSOCIATES, 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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MEDISEPTIC ANTIINFECTANT

BENZALKONIUM CHLORIDE 0.1% ..........ANTIBACTERIAL

USE AS A HAND SANITISER TO HELP REDUCE BACTERIA ON SKIN
FOR HAND HYGIENE

WARNINGS

FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. NOT FOR FOOD USE. DO NOT INGEST.

AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH EYES WITH WATER.

IF IRRITATION OR REDNESS DEVELOPS.

IF IRRITATION OR REDNESS PERSISTS MORE THAN 72 HOURS.

APPLY APPROX. 3-5MLS OF UNDILUTED PRODUCT INTO THE PALM OF HANDS AND RUB IN FOR 1 MINUTE. IN PARTICULAR TAKE INTO ACCOUNT THUMBS AND FINGERTIPS, AS THEY HAVE MOST FREQUENT CONTACT WITH CONTAMINATED SURFACES AND OBJECTS. FREQUENCY: REPEAT AS NEEDED TO RENEW PROTECTION.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

WATER, ORGANIC ACIDS, CATIONIC POLYMERS.

READY TO USE. DO NOT DILUTE.

Other Information

Do not mix with acids and alkalis. Keep container tightly closed after use and keep cool.

Usage

Use as a skin sanitizer to help reduce bacteria on skin. Repeat as necessary.

DRUG FACTS

ACTIVE INGREDIENTS PURPOSE

BENZALKONIUM CHLORIDE 0.1% .......ANTIBACTERIAL

LABEL $javascript:previewimage('May\u002026\u00202020\u0020MediSeptic_label_USA_50mL$

MEDISEPTIC ANTIINFECTANT
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78874-500
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
POVIDONE K15 (UNII: E54VE15114)	0.24 g in 100 mL
WATER (UNII: 059QF0KO0R)	98.5 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.9 g in 100 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI)	0.01 g in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ)	0.25 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 78874-500-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 78874-500-01	10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2020
3	NDC: 78874-500-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 78874-500-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 78874-500-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
6	NDC: 78874-500-55	550 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
7	NDC: 78874-500-99	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
8	NDC: 78874-500-49	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
9	NDC: 78874-500-19	18900 mL in 1 JUG; Type 0: Not a Combination Product	06/01/2020
10	NDC: 78874-500-54	200000 mL in 1 DRUM; Type 0: Not a Combination Product	06/01/2020
11	NDC: 78874-500-27	1000000 mL in 1 TANK; Type 0: Not a Combination Product	06/01/2020
12	NDC: 78874-500-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
13	NDC: 78874-500-77	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2020	05/10/2022

Labeler - PORTOFINO & ASSOCIATES, LLC (101107949)

Registrant - PORTOFINO & ASSOCIATES, LLC (101107949)

Revised: 5/2022

Document Id: de9dc309-bf16-7c97-e053-2a95a90a0d33

Set id: a76e69d3-e5df-2047-e053-2995a90ad942

Version: 5

Effective Time: 20220509