SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS- chlorhexidine gluconate 
Sage Products, Inc.

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2% Chlorhexidine Gluconate Cloth and 3M Skin and Nasal Antiseptic

Active ingredient

chlorhexidine gluconate 2% solution

Povidone-Iodine USP, 5%

Purpose

Antiseptic

Keep out of reach of children.

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

Uses

Warnings

For external use only

Do not use

When using this product

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.

Directions

2% Chlorhexidine Gluconate Cloth

To open package

Or

Directions

3M Skin and Nasal Antiseptic

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 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

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

2% chlorhexidine gluconate cloth

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

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

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

NDC 17518–060–04
SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS 
chlorhexidine gluconate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-008
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-008-281 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKAGE
Part 21 BOTTLE 4 mL
Part 1 of 2
CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate cloth
Product Information
Item Code (Source)NDC:53462-705
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chlorhexidine gluconate (UNII: MOR84MUD8E) (chlorhexidine - UNII:R4KO0DY52L) chlorhexidine gluconate500 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-705-236 in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02166902/01/2006
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 POUCH
1NDC:17518-060-044 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02166902/06/2012
Labeler - Sage Products, Inc. (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products, Inc.054326178MANUFACTURE(53462-008)
Establishment
NameAddressID/FEIBusiness Operations
3M ESPE Dental Products078404534MANUFACTURE(17518-060, 53462-705)
Establishment
NameAddressID/FEIBusiness Operations
3M Health Care LTD218829455MANUFACTURE(17518-060, 53462-705)

Revised: 10/2012
Document Id: d36bf0aa-9dec-3328-cab8-8fc6748dafb3
Set id: d36bf0aa-9dec-3328-cab8-8fc6748dafb3
Version: 1
Effective Time: 20121022
 
Sage Products, Inc.