Foaming Chlorhexidine Gluconate

Manufacturer
Protect U Guard, LLC
Effective date
2021-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:38

Label at a glance#

ProductFoaming Chlorhexidine Gluconate
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure13 sections

Indications and uses

Antimicrobial skin cleanser helps reduce bacteria for skin wound and skin cleansing surgical hand scrub healthcare personnel handwash

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate 4% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Antimicrobial skin cleanser helps reduce bacteria

for skin wound and skin cleansing

surgical hand scrub

healthcare personnel handwash

Warnings

WARNINGS SECTION

For external use only.

Do Not Use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

May discolor some fabrics. Do not use with bleach.

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, lauramine oxide, isopropyl alcohol, gluconolactone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chlorhexidine 18bChlorhexidine 18b

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSN1
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCD1
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSY1
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71788-016-10Foaming Chlorhexidine Gluconate1000 mL in 1 BOTTLE, PUMPLIQUID10001
71788-016-20Foaming Chlorhexidine Gluconate4 in 1 CARTONLIQUID41
71788-016-50Foaming Chlorhexidine Gluconate530 mL in 1 BOTTLE, PUMPLIQUID5301
71788-016-60Foaming Chlorhexidine Gluconate12 in 1 CARTONLIQUID121
71788-016-70Foaming Chlorhexidine Gluconate100 mL in 1 BOTTLE, PUMPLIQUID1001
71788-016-80Foaming Chlorhexidine Gluconate24 in 1 CARTONLIQUID241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71788-016FOAMING CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE) LIQUID [PROTECT U GUARD, LLC]1Legacy NDC, 6 package rows20210413_bfcb349f-8ab6-54aa-e053-2a95a90a34ce.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71788-01671788-016-70, 71788-016-80, 71788-016-10, 71788-016-20, 71788-016-50, 71788-016-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bfcb349f-8ab7-54aa-e053-2a95a90a34cebfcb349f-8ab6-54aa-e053-2a95a90a34ce2021-04-12WarningsExact identifier
spl id: bfcb349f-8ab7-54aa-e053-2a95a90a34ce
spl set id: bfcb349f-8ab6-54aa-e053-2a95a90a34ce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.