ANTISEPTIC SKIN CLEANSER description, usages, side effects, indications, overdosage, supplying and lots more!

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ANTISEPTIC SKIN CLEANSER

AVA, Inc.
AVA, Inc.

Antiseptic Skin Cleanser(Chlorhexidine Gluconate 4% Solution)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Chlorhexidine gluconate 4% solution

Purposes

surgical hand scrub
healthcare personnel handwash
patient preoperative skin preparation
skin wound and general skin cleansing

ANTISEPTIC SKIN CLEANSER Uses

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

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 preparation 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 instilled in the middle ear through perforated eardrums
  • 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. 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.

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

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 and 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

ANTISEPTIC SKIN CLEANSER Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

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

Questions or comments?

Call 1-855-552-8274

Manufactured by:
AVA, Inc.
7051 S. Adams St.
Willowbrook, IL 60527

PRINCIPAL DISPLAY PANEL - 947 mL Bottle Label

NDC 42939-102-04

ANTISEPTIC SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

32 fl.oz. (974 mL)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

AVA Incorporated

Lot:

Exp:

ANTISEPTIC SKIN CLEANSER

ANTISEPTIC SKIN CLEANSER

Chlorhexidine Gluconate SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42939-102
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
chlorhexidine gluconate CHLORHEXIDINE 4 g

Inactive Ingredients

Ingredient Name Strength
GLUCONOLACTONE
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)
ISOPROPYL ALCOHOL
LAURAMINE OXIDE
PEG-75 LANOLIN
water
TRIDECYL ALCOHOL

Product Characteristics

Color
YELLOW

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42939-102-04 947 in 1 BOTTLE
2 NDC:42939-102-03 473 in 1 BOTTLE
3 NDC:42939-102-02 237 in 1 BOTTLE
4 NDC:42939-102-01 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-12-06


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