APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution 
Aplicare, Inc.

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Drug Facts

Active ingredient

Chlorhexidine Gluconate 4% solution

Purpose

Antiseptic

Uses

Warnings

For external use only

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin prep of the head or face

When using this product

  • single use when used for patient preoperative skin preparation
  • keep out of eyes, ears and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when installed in the middle ear through perforated ear drums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of the skin

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. This 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 skin cleansing:

Inactive ingredients

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

Questions or comments?

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

4% Chlorhexidine Gluconate

82 286 Label

APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-1272-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:52380-1272-8237 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:52380-1272-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:52380-1272-7946 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:52380-1272-93800 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
Labeler - Aplicare, Inc. (107255002)

Revised: 8/2015
Document Id: 1d107814-357c-68e4-e054-00144ff88e88
Set id: 45c1e1b3-6d56-4fa2-a332-4e88d2f416dc
Version: 13
Effective Time: 20150811
 
Aplicare, Inc.