CHLORHEXIDINE GLUCONATE APPLICATOR- chlorhexidine gluconate applicator solution
Miraclean Technology Co.,Ltd

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 ingredients

Chlorhexidine gluconate,（ 2% solution ），
Isopropyl alcohol,（ 70% solution ）

ask a doctor

If any irritation or allergic reaction occurs

Do not use

■ If any open wounds
■ If package damaged or expired
■ If the patient is allergic to chlorhexidine gluconate or any other ingredient in this product

Keep out of the reach of children

Purpose

Antiseptic

Stop use and ask a doctor

If any irritation or allergic reaction occurs

Inactive ingredient

■ Water

Other information

■ Stored between 4-30℃
Avoid exclusive heat above 40℃ (104° F)

Directions

Peel apart the package and remove the applicator
Pull and remove the ring collar lock from the handle
Wet the treatment area with the fluid
Press down the handle to activate and release the solution flow into the sponge pad

Use

For skin preparation before surgery

Warnings

■ Single-use product
■ Keep away from flames or sparks
■ Keep out of the reach of children

LABEL

LABEL 10.5ML label 26ml

CHLORHEXIDINE GLUCONATE APPLICATOR
chlorhexidine gluconate applicator solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73565-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mg in 100 mg
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 mg in 100 mg

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73565-001-26	26 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/17/2020
2	NDC:73565-001-10	10.5 mg in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/17/2020

Labeler - Miraclean Technology Co.,Ltd (529423940)

Name	Address	ID/FEI	Business Operations
Establishment
Miraclean Technology Co.,Ltd		529423940	manufacture(73565-001)

Revised: 1/2020

Document Id: 9ee5676c-3662-44e1-e053-2995a90a9214

Set id: 9ee5676c-3661-44e1-e053-2995a90a9214

Version: 1

Effective Time: 20200115

Miraclean Technology Co.,Ltd