FOAMING CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate liquid

Foaming Chlorhexidine Gluconate by

Drug Labeling and Warnings

Foaming Chlorhexidine Gluconate by is a Otc medication manufactured, distributed, or labeled by Protect U Guard, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Chlorhexidine gluconate 4% w/v

Purpose

Antiseptic

Uses

Antimicrobial skin cleanser helps reduce bacteria

for skin wound and skin cleansing

surgical hand scrub

healthcare personnel handwash

Warnings

For external use only.

Do Not Use

if you are allergic to chlorhexidine gluconate or any other ingredient(s) in this preparation

as a patient preoperative skin preparation of the head or face

in contact with the meninges or in the genital area

on wounds involving more than the superficial layers of skin

as a general skin cleanser

When using this product

keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures, or may cause deafness when instilled in the middle ear through perforated eardrums.

if contact occurs in any of these areas, rinse with cold water right away

do not inhale or ingest

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs and lasts 72 hours. These may be signs of a serious condition.

Directions

use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.

skin wound and skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly

surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with 5mL of the product with brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.

healthcare personnel handwash. Wet hands with water. Dispense 5 mL of the product into cupped hands. Wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Other Information

May discolor some fabrics. Do not use with bleach.

Store between 20-25° C ( 68-77° F). Avoid excessive heat.

Inactive ingredients:

Water, lauramine oxide, isopropyl alcohol, gluconolactone.

Questions or comments?

1-813-815-0530 or www.protectuguard.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOAMING CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71788-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71788-016-80	24 in 1 CARTON	04/13/2021
1	NDC: 71788-016-70	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 71788-016-20	4 in 1 CARTON	04/13/2021
2	NDC: 71788-016-10	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 71788-016-60	12 in 1 CARTON	04/13/2021
3	NDC: 71788-016-50	530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part349	04/13/2021

Labeler - Protect U Guard, LLC (080070945)

Establishment
Name	Address	ID/FEI	Business Operations
Protect U Guard, LLC		080070945	manufacture(71788-016) , pack(71788-016) , repack(71788-016)