FOAMING CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate liquid 
Protect U Guard, 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

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

Chlorhexidine 18b

FOAMING CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71788-016-8024 in 1 CARTON04/13/2021
1NDC:71788-016-70100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:71788-016-204 in 1 CARTON04/13/2021
2NDC:71788-016-101000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:71788-016-6012 in 1 CARTON04/13/2021
3NDC:71788-016-50530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34904/13/2021
Labeler - Protect U Guard, LLC (080070945)
Establishment
NameAddressID/FEIBusiness Operations
Protect U Guard, LLC080070945manufacture(71788-016) , pack(71788-016) , repack(71788-016)

Revised: 4/2021
Document Id: bfcb349f-8ab7-54aa-e053-2a95a90a34ce
Set id: bfcb349f-8ab6-54aa-e053-2a95a90a34ce
Version: 1
Effective Time: 20210412
 
Protect U Guard, LLC