APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution

Aplicare Antiseptic Chlorhexidine Gluconate by

Drug Labeling and Warnings

Aplicare Antiseptic Chlorhexidine Gluconate by is a Otc medication manufactured, distributed, or labeled by Aplicare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Chlorhexidine Gluconate 2% solution

Purpose

Surgical hand scrub

Healthcare personnel handwash

Patient preoperative skin preparation

Skin wound and general skin cleansing

Warning
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

• 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.

DOSAGE & ADMINISTRATION

Directions

Surgical hand scrub

• wet hands and forearms under running water
• scrub for 3 minutes with about 5 ml of product and a wet brush paying close attention to the nails, cuticles and interdigital spaces
• a separate nail cleaner may be used
• rinse thoroughly
• wash for an additional 3 minutes with 5 ml of product and rinse under running water
• dry thoroughly

Healthcare personnel handwash

• wet hands with water
• dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
• rinse and dry thoroughly

Patient preoperative skin preparation

• apply product liberally to surgical site and swab for at least 2 minutes
• dry with a sterile towel
• repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing

• thoroughly rinse the area to be cleaned with water
• apply the minimum amount of product necessary to cover the skin or wound area and wash gently
• rinse again thoroughly
  

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

2% Chlorhexidine Gluconate, 4 oz.

INGREDIENTS AND APPEARANCE

APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1274
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)	Chlorhexidine Gluconate	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Anhydrous Citric Acid (UNII: XF417D3PSL)
Cocamide Diethanolamine (UNII: 92005F972D)
Hydroxyethyl Cellulose (140 CPS AT 5%) (UNII: 8136Y38GY5)
Isopropyl Alcohol (UNII: ND2M416302)
Lauramine Oxide (UNII: 4F6FC4MI8W)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1274-4	120 g in 1 BOTTLE
2	NDC: 52380-1274-8	240 g in 1 BOTTLE
3	NDC: 52380-1274-6	480 g in 1 BOTTLE
4	NDC: 52380-1274-7	960 g in 1 BOTTLE
5	NDC: 52380-1274-9	3785 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	09/01/1998

Labeler - Aplicare, Inc. (107255002)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare, Inc.		058377631	repack