B10800 Ndc 10819-1080-1

B10800 Ndc 10819-1080-1
SPL v10
SPL
SPL Set ID db61e7fd-c421-4e3c-bc88-0343230273de
Route
TOPICAL
Published
Effective Date 2014-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (31.5 mg) Isopropyl Alcohol (0.7 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 2013-01-15

Description

Chlorhexidine gluconate 3.15% w/v Isopropyl alcohol 70% v/v

Purpose

Antiseptic Antiseptic


Medication Information

Purpose

Antiseptic

Antiseptic

Description

Chlorhexidine gluconate 3.15% w/v Isopropyl alcohol 70% v/v

Use

for the preparation of the patient's skin prior to an injection

Warnings
  • For external use only 
  • Flammable, keep away from fire or flame
  • Do not use with electrocautery procedures
Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • maximum treatment area for one swab is approximately 2.5 by 2.5 inches (6 by 6 cm)
  • tear open packet and remove swab. Do not unfold swab.
  • prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth strokes for 15 seconds.
  • allow the prepped area to air dry for 30 seconds
  • do not blot or wipe dry
  • discard after a single use
Do Not Use
  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar puncture or in contact with the meninges
  • on open skin wounds or as a general skin cleanser
  • under occlusive patch
Allergy Alert

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

if an allergic reaction occurs, stop use and seek medical help right away

Other Information
  • store between 68-77°F (20-25°C)
  • avoid freezing and excessive heat above 104°F (40°C)
  • for hospital and professional use only
Active Ingredients

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Inactive Ingredients

USP purified water

When Using This Product

keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

_________________________________________________________________

Stop Use and Ask A Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Packet Label

Box Label


Structured Label Content

Use

for the preparation of the patient's skin prior to an injection

Purpose

Antiseptic

Antiseptic

Warnings
  • For external use only 
  • Flammable, keep away from fire or flame
  • Do not use with electrocautery procedures
Directions
  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • maximum treatment area for one swab is approximately 2.5 by 2.5 inches (6 by 6 cm)
  • tear open packet and remove swab. Do not unfold swab.
  • prior to injection, apply swab to the procedure site by holding swab between thumb and index finger. Apply swab to skin using repeated back-and-forth strokes for 15 seconds.
  • allow the prepped area to air dry for 30 seconds
  • do not blot or wipe dry
  • discard after a single use
Do Not Use (Do not use)
  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • for lumbar puncture or in contact with the meninges
  • on open skin wounds or as a general skin cleanser
  • under occlusive patch
Allergy Alert (Allergy alert)

This product may cause a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

if an allergic reaction occurs, stop use and seek medical help right away

Other Information (Other information)
  • store between 68-77°F (20-25°C)
  • avoid freezing and excessive heat above 104°F (40°C)
  • for hospital and professional use only
Active Ingredients (Active ingredients)

Chlorhexidine gluconate 3.15% w/v

Isopropyl alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

USP purified water

When Using This Product (When using this product)

keep out of eyes, ears, mouth and mucous membranes. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

_________________________________________________________________

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

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Packet Label

Box Label


Advanced Ingredient Data


Raw Label Data

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