4de58778-9ae1-54f0-e054-00144ff8d46c

SPL v2
SPL
SPL Set ID 4de58778-9ae1-54f0-e054-00144ff8d46c
Route
topical
Published
Effective Date 2017-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (0.7 mL) chlorhexidine (20 mg)
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
Active Ingredient

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

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


Structured Label Content

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
Active Ingredient (55106-9)

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

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
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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)