BD E-Z SCRUB 107- chlorhexidine gluconate solution

BD E-Z Scrub 107 by

Drug Labeling and Warnings

BD E-Z Scrub 107 by is a Otc medication manufactured, distributed, or labeled by Becton, Dickinson and Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

4% Chlorhexidine gluconate w/v

Purpose

Antiseptic

Use

preoperative cleaning of healthcare personnel arms and hands.

Warnings

For external use only.

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.

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.

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.

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

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

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

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Package Label

BD E-Z Scrub™ 107
Surgical Scrub Brush/Sponge
4% CHG
NDC: 17271-107-03
REF 371073

INGREDIENTS AND APPEARANCE

BD E-Z SCRUB 107 
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17271-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chlorhexidine gluconate (UNII: MOR84MUD8E) (chlorhexidine - UNII:R4KO0DY52L)	chlorhexidine gluconate	40 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C Red No. 40 (UNII: WZB9127XOA)
hydrochloric acid (UNII: QTT17582CB)
lauric diethanolamide (UNII: I29I2VHG38)
nonoxynol-12 (UNII: 6NR43D77O6)
peg-150 dilaurate (UNII: CF607I8E19)
peg-75 lanolin (UNII: 09179OX7TB)
water (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17271-107-03	10 in 1 BOX	10/24/1989
1		30 in 1 CARTON
1		18 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072525	10/24/1989

Labeler - Becton, Dickinson and Company (124987988)

Establishment
Name	Address	ID/FEI	Business Operations
Becton, Dickinson and Company		124987988	MANUFACTURE(17271-107)