SPL v2
SPL
SPL Set ID 4de58778-9ac1-54f0-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (20 mg) Isopropyl Alcohol (0.7 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-18

Description

Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v


Medication Information

Warnings and Precautions

Warnings

For external use only. Flammable keep away from fire or flame.

  • do not use with electrocautery procedures

Do not use

  • On patients with allergies to Chlorhexidine gluconate or Isopropyl alcohol
  • As a general skin cleanser or on open wounds
Indications and Usage

Use prior to surgery to prepare patient’s skin. Helps in the reduction of potentially harmful bacteria which can cause skin infections.

Dosage and Administration

Directions

  • The maximum treatment area is 2.5” x 2.5”
  • Point directional arrow downward
  • Hold applicator at both ends firmly and with a flexible firm motion break center seal at perforations.
  • Remove side of applicator case with applicator tip and discard other side according to institutional

procedures.

  • Apply solution to site using lateral stokes in both directions. (30 seconds for dry sites and 2

minutes for moist sites)

  • Allow area to dry sufficiently. Dry sites for 30 seconds and moist areas for 1 minute.
  • Single use only. Discard remaining solution. Entire solution is not required to be used
Description

Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

Section 44425-7



Other information

■ store between 15–30 °C (59–86 °F)

■ avoid freezing and excessive heat above 40 °C (104 °F)

Section 50565-1

Keep out of reach of children contact Poison Control or get medical help immediately.

Section 50566-9

Stop use immediately if irritation or allergic reaction occurs. Contact your doctor immediately!

Section 51727-6

Inactive ingredients USP purified water

Section 51945-4

Section 55105-1

Purposes

Antiseptic

Section 55106-9

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v


Structured Label Content

Indications and Usage (34067-9)

Use prior to surgery to prepare patient’s skin. Helps in the reduction of potentially harmful bacteria which can cause skin infections.

Dosage and Administration (34068-7)

Directions

  • The maximum treatment area is 2.5” x 2.5”
  • Point directional arrow downward
  • Hold applicator at both ends firmly and with a flexible firm motion break center seal at perforations.
  • Remove side of applicator case with applicator tip and discard other side according to institutional

procedures.

  • Apply solution to site using lateral stokes in both directions. (30 seconds for dry sites and 2

minutes for moist sites)

  • Allow area to dry sufficiently. Dry sites for 30 seconds and moist areas for 1 minute.
  • Single use only. Discard remaining solution. Entire solution is not required to be used
Warnings and Precautions (34071-1)

Warnings

For external use only. Flammable keep away from fire or flame.

  • do not use with electrocautery procedures

Do not use

  • On patients with allergies to Chlorhexidine gluconate or Isopropyl alcohol
  • As a general skin cleanser or on open wounds
Section 44425-7 (44425-7)



Other information

■ store between 15–30 °C (59–86 °F)

■ avoid freezing and excessive heat above 40 °C (104 °F)

Section 50565-1 (50565-1)

Keep out of reach of children contact Poison Control or get medical help immediately.

Section 50566-9 (50566-9)

Stop use immediately if irritation or allergic reaction occurs. Contact your doctor immediately!

Section 51727-6 (51727-6)

Inactive ingredients USP purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purposes

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)