CHLORHEXIDINE GLUCONATE APPLICATOR solution

Chlorhexidine Gluconate Applicator by

Drug Labeling and Warnings

Chlorhexidine Gluconate Applicator by is a Otc medication manufactured, distributed, or labeled by Miraclean Technology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

CHLORHEXIDINE GLUCONATE APPLICATOR 
chlorhexidine gluconate applicator solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73565-011
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73565-011-26	26 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/17/2020
2	NDC: 73565-011-10	10.5 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/17/2020

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

Labeler - Miraclean Technology Co.,Ltd (529423940)

Establishment
Name	Address	ID/FEI	Business Operations
Miraclean Technology Co.,Ltd		529423940	manufacture(73565-011)