SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS- chlorhexidine gluconate kit

Skin antisepsis, oral cleansing, nasal antisepsis by

Drug Labeling and Warnings

Skin antisepsis, oral cleansing, nasal antisepsis by is a Otc medication manufactured, distributed, or labeled by Sage Products, Inc., 3M ESPE Dental Products, 3M Health Care LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

chlorhexidine gluconate 2% solution

Povidone-Iodine USP, 5%

PURPOSE

Purpose

Antiseptic

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.

INDICATIONS & USAGE

Uses

• helps reduce bacteria that can potentially cause skin infection
• for preparation of skin prior to surgery

WARNINGS

Warnings

For external use only

STOP USE

Do not use

• on patients with known allergies to chlorhexidine gluconate or any other ingredients in this product
• for lumbar punctures or in contact with the meninges
• on open skin wounds or as a general skin cleanser

WHEN USING

When using this product

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

Do not use if you have a known sensitivity to iodine or any other ingredient in this product. Do not use in eyes. If product gets into eyes, flush immediately with water.  Do not use on infants less than 2 months old due to the risk of increased blood iodine levels.

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

DOSAGE & ADMINISTRATION

Directions

2% Chlorhexidine Gluconate Cloth

• use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
• do not microwave
• product and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.

To open package

• holding top of package in one hand, lift flap on backside of package with other hand
• grasp flap at top and pull down to tear flap away and expose foam
• hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.

Or

• using sterile scissors, cut off end seal of package
• transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination
• use first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas.
• dry surgical sites (such as abdomen or arm): use one cloth to cleanse each 161 cm2 area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute. Do not rinse.
• moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm2 area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.  Allow area to air dry for one (1) minute. Do not rinse.
• discard each cloth after a single use
• after package has been opened discard any unused cloths

Directions

3M Skin and Nasal Antiseptic

• open package and remove bottle and swabs
• unscrew cap by turning cap counter-clockwise

Skin Application:

1. Apply to clean dry skin.
2. Dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
3. Scrub prep site for 2 minutes working from clean to dirty using both sides of the swab.
4. Repeat steps 2 & 3 using second swab.
5. Allow prep solution to dry. Do not blot.

Nasal Application:

1. Use a tissue to clean the inside of both nostrils including the inside tip of nostril. Discard.
2. Tilting the bottle slightly, dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
3. Insert swab comfortably into one nostril and rotate for 15 seconds covering all surfaces. Then focus on the inside tip of nostril and rotate for an additional 15 seconds. (swab 1)
4. Using a new swab: Repeat steps 2 & 3 with the other nostril. (swab 2)
5. Repeat the application in both nostrils using a fresh swab each time. (swabs 3 & 4)
6. Do not blow nose. If solution drips out of nose, it can be lightly dabbed with a tissue.

INACTIVE INGREDIENT

Inactive ingredients

2% Chlorhexidine Gluconate Cloth
aloe vera, dimethicone, fragrance, glucono-delta-lactone, glycerin, Igepal, polysorbate 20, propylene glycol, USP purified water

cloth: polyester

Inactive ingredients

3M Skin and Nasal Antiseptic
Lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, steareth-100, water, xylitol

PRINCIPAL DISPLAY PANEL

2% Chlorhexidine Gluconate* Cloth
NDC 053462–705–23

PRINCIPAL DISPLAY PANEL

3M Skin and Nasal Antiseptic
NDC 17518–060–04

PRINCIPAL DISPLAY PANEL

3M Skin and Nasal Antiseptic
NDC 17518–060–04

INGREDIENTS AND APPEARANCE

SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS 
chlorhexidine gluconate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-008

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-008-28	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKAGE	6
Part 2	1 BOTTLE	4 mL

Part 1 of 2

CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate cloth

Product Information
Item Code (Source)	NDC: 53462-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chlorhexidine gluconate (UNII: MOR84MUD8E) (chlorhexidine - UNII:R4KO0DY52L)	chlorhexidine gluconate	500 mg

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
nonoxynol-9 (UNII: 48Q180SH9T)
polysorbate 20 (UNII: 7T1F30V5YH)
dimethicone 350 (UNII: 2Y53S6ATLU)
propylene glycol (UNII: 6DC9Q167V3)
aloe vera leaf (UNII: ZY81Z83H0X)
glycerin (UNII: PDC6A3C0OX)
gluconolactone (UNII: WQ29KQ9POT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-705-23	6 in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021669	02/01/2006

Part 2 of 2

3M SKIN AND NASAL ANTISEPTIC 
3m skin and nasal antiseptic solution

Product Information
Item Code (Source)	NDC: 17518-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	POVIDONE-IODINE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LACTIC ACID (UNII: 33X04XA5AT)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM IODIDE (UNII: F5WR8N145C)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 POUCH
1	NDC: 17518-060-04	4 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021669	02/06/2012

Labeler - Sage Products, Inc. (054326178)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Products, Inc.		054326178	MANUFACTURE(53462-008)

Establishment
Name	Address	ID/FEI	Business Operations
3M ESPE Dental Products		078404534	MANUFACTURE(17518-060, 53462-705)

Establishment
Name	Address	ID/FEI	Business Operations
3M Health Care LTD		218829455	MANUFACTURE(17518-060, 53462-705)