4% CHG SKIN CLEANSING KIT- fiber, medical, absorbent   
Aplicare, Inc.

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Active ingredient

Chlorhexidine Gluconate 4% Solution

Purposes

surgical hand scrub

healthcare personnel handwash

patient preoperative skin preparation

skin wound and general skin cleansing

Uses

Warnings

For external use only

Do not use:

When using this product

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.

Directions

Surgical hand scrub

Healthcare personnel handwash

Patient preoperative skin preparation

Skin wound and general cleansing

Other information

Inactive ingredients

cocamide DEA, fragrance POFL 147, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions or comments?

1-800-760-3236 (Mon. - Fri. - 8:30 AM - 5:00 PM EST)

4% Chlorhexidine Gluconate, 128 oz

82 286 Label

4% CHG SKIN CLEANSING KIT 
fiber, medical, absorbent kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NHRIC:52380-7001
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:52380-7001-01 in 1 KIT; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 21 BOTTLE 118 mL
Part 1 of 2
NON-COTTON CLEANSING WIPES 
fiber, medical, absorbent
Product Information
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceABC07/01/2014
Part 2 of 2
APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate solution
Product Information
Item Code (Source)NDC:52380-1272
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL ALCOHOL (UNII: 8I9428H868)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1272-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912509/01/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceABC07/01/2014
Labeler - Aplicare, Inc. (058377631)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare, Inc.058377631pack(52380-7001)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium, Inc.007470579manufacture(52380-1272)

Revised: 8/2015
Document Id: 46fb58c8-97eb-41fe-8c42-aac08ddd9596
Set id: 65f87900-8d23-4fb3-be44-1d116aedac78
Version: 4
Effective Time: 20150820
 
Aplicare, Inc.