SPL v1
SPL
SPL Set ID 9ee5676c-3661-44e1-e053-2995a90a9214
Route
TOPICAL
Published
Effective Date 2020-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 g) Chlorhexidine (2 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-02-17

Description

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

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

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

Use

For skin preparation before surgery

Label

Warnings

■ Single-use product

■ Keep away from flames or sparks

■ Keep out of the reach of children

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

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

Ask A Doctor

If any irritation or allergic reaction occurs

Other Information

■ Stored between 4-30℃

Avoid exclusive heat above 40℃ (104° F)

Active Ingredients

Chlorhexidine gluconate,( 2% solution ) ,

Isopropyl alcohol,( 70% solution )

Inactive Ingredient

■ Water

Stop Use and Ask A Doctor

If any irritation or allergic reaction occurs

Keep Out of the Reach of Children

Keep out of the reach of children


Structured Label Content

Use

For skin preparation before surgery

Label (LABEL)

Purpose

Antiseptic

Warnings

■ Single-use product

■ Keep away from flames or sparks

■ Keep out of the reach of children

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

Do Not Use (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

Ask A Doctor (ask a doctor)

If any irritation or allergic reaction occurs

Other Information (Other information)

■ Stored between 4-30℃

Avoid exclusive heat above 40℃ (104° F)

Active Ingredients (Active ingredients)

Chlorhexidine gluconate,( 2% solution ) ,

Isopropyl alcohol,( 70% solution )

Inactive Ingredient (Inactive ingredient)

■ Water

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If any irritation or allergic reaction occurs

Keep Out of the Reach of Children (Keep out of the reach of children)

Keep out of the reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)