SERDAEN  - chlorhexidine diacetate soap 
Browne Hansen LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active Ingredient

Chlorhexidine Diacetate 1%

Inactive Ingredients

Water, Cola Det SDC, Sodium Xylem Sulfate, Tocopheryl Acetate, Fragrance

Purpose

Antimicrobial

Uses

Prevent overgrowth of bacteria prior to surgical procedure

Prevent recurrent bacterial infections

Prevent infections around superficial wounds

Keep out of reach of children. If swallowed, get medical help

or contact a poison control center right away.

Warnings

For external use only.

Do not use:

If allergic to Chlorhexidine or other ingredients in formulation

In contact with the genital area

On wounds that exceed the superficial layer of skin.

When using this product

Avoid eye contact. Should contact occur,

rinse thoroughly with water.

Discontinue use and consult a health care practitioner

if irritation or allergic reaction develops.

Directions

Apply liberally to moistened area, wash and rinse thoroughly.

All product should be rinsed and dried immediately

copy of label

SERDAEN  
chlorhexidine diacetate soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56149-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE48 mg  in 3 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56149-002-023 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2013
Labeler - Browne Hansen LLC (962275843)

Revised: 6/2013
Document Id: cb80b579-2303-4261-8eba-426e54b7ffc7
Set id: e34e6caa-3360-4549-8a84-d8adcab1b3bb
Version: 2
Effective Time: 20130613
 
Browne Hansen LLC