SPL v9
SPL
SPL Set ID 7c173111-11de-4585-af06-b329fe029036
Route
TOPICAL
Published
Effective Date 2011-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (40 g)
Inactive Ingredients
Fd&c Red No. 40 Hydrochloric Acid Lauric Diethanolamide Nonoxynol-12 Peg-150 Distearate Peg-75 Lanolin Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 1989-10-24

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

preoperative cleaning of healthcare personnel arms and hands.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, gets in eye or ear, get medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if adverse reactions occur. Irritation, sensitization and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas.

Section 51945-4

Principal Display Panel – Carton Label

BD

BD E-Z Scrub™ 107


Surgical Scrub Brush/Sponge

and Nail Cleaner with

4% Chlorhexidine Gluconate

4% CHG

CONTAINS:

30

NOTE: SEE BACK PANEL

FOR EASY INSTRUCTIONS

REF 371073

NDC 17271-107-03

U.S. Patent 5, 164, 107

Warnings

For external use only.

Directions
  • wet hands and forearms to the elbows with warm water
  • use nail cleaner and apply scrub solution from sponge side
  • work up lather
  • scrub nails, cuticles and interdigital spaces thoroughly for 3 minutes with brush side and hands and forearms with the sponge side
  • rinse with warm water
  • repeat scrub for 3 more minutes, use the sponge side only. Add water as necessary to produce the desired level of suds.
  • rinse hands and arms thoroughly
  • dry thoroughly
Do Not Use
  • as a preoperative skin preparation of the face or head
  • in eyes, ears and mouth
  • if you have a sensitivity to chlorhexidine gluconate or its components.
Questions?

1-800-453-4538 Monday to Friday, 8 a.m. to 5 p.m. MST

Active Ingredient

4% Chlorhexidine gluconate w/v

Other Information
  • avoid excessive heat 40°C (104°F)
  • discard after single use.
Inactive Ingredients

FD&C red #40, hydrochloric acid, lauramide DEA, nonoxynol-12, peg-6000 distearate, peg-75 lanolin, purified water USP, sodium hydroxide

When Using This Product
  • avoid contact with meninges
  • chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated ear drums
  • chlorhexidine gluconate solution has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures
  • if chlorhexidine gluconate solution should contact these areas, rinse out promptly and thoroughly with water.

Structured Label Content

Use

preoperative cleaning of healthcare personnel arms and hands.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, gets in eye or ear, get medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if adverse reactions occur. Irritation, sensitization and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas.

Section 51945-4 (51945-4)

Principal Display Panel – Carton Label

BD

BD E-Z Scrub™ 107


Surgical Scrub Brush/Sponge

and Nail Cleaner with

4% Chlorhexidine Gluconate

4% CHG

CONTAINS:

30

NOTE: SEE BACK PANEL

FOR EASY INSTRUCTIONS

REF 371073

NDC 17271-107-03

U.S. Patent 5, 164, 107

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • wet hands and forearms to the elbows with warm water
  • use nail cleaner and apply scrub solution from sponge side
  • work up lather
  • scrub nails, cuticles and interdigital spaces thoroughly for 3 minutes with brush side and hands and forearms with the sponge side
  • rinse with warm water
  • repeat scrub for 3 more minutes, use the sponge side only. Add water as necessary to produce the desired level of suds.
  • rinse hands and arms thoroughly
  • dry thoroughly
Do Not Use (Do not use)
  • as a preoperative skin preparation of the face or head
  • in eyes, ears and mouth
  • if you have a sensitivity to chlorhexidine gluconate or its components.
Questions?

1-800-453-4538 Monday to Friday, 8 a.m. to 5 p.m. MST

Active Ingredient (Active ingredient)

4% Chlorhexidine gluconate w/v

Other Information (Other information)
  • avoid excessive heat 40°C (104°F)
  • discard after single use.
Inactive Ingredients (Inactive ingredients)

FD&C red #40, hydrochloric acid, lauramide DEA, nonoxynol-12, peg-6000 distearate, peg-75 lanolin, purified water USP, sodium hydroxide

When Using This Product (When using this product)
  • avoid contact with meninges
  • chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated ear drums
  • chlorhexidine gluconate solution has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures
  • if chlorhexidine gluconate solution should contact these areas, rinse out promptly and thoroughly with water.

Advanced Ingredient Data


Raw Label Data

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