Antiseptic skin cleanser liquid

Active ingredients

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing

Warnings

For external use only

Allergy alert:This product may cause severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergc reaction occurs, stop use and seek medical help right away.

Do not use

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardurms.
  • 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 advised by a health care provider

Directions

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

Healthcare personnel handwash:

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

Skin wound and normal 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

Other information

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

Inactive ingredients

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

Questions or comments?

call 1-800-587-3721Monday through Friday 8:00 AM to 4:30 PM CST.

Ingredients and appearance - Product information

Antiseptic skin cleanser liquid- Chlorhexidine gluconate 4%

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-3678
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Chlorhexidine gluconate ( UNII: MOR84MUD8E)( Chlorhexidine - UNII: R4KO0DY52L ) 4 mgin 100 mL

Inactive Ingredients

Ingredient Name Code
Gluconolactone ( UNII: WQ29KQ9POT)
Lauramine oxide ( UNII: 4F6FC4MI8W)
Coco diethanolamide ( UNII: 92005F972D)
Peg-75 lanolin ( UNII: 09179OX7TB)
Hydroxyethyl cellulose (2000 cps at 1%) ( UNII: S38J6RZN16)
Isopropyl alcohol ( UNII: ND2M416302)
Water ( UNII: 059QF0KO0R)
Tridecyl alcohol ( UNII: 8I9428H868)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 11822-3678-8 237mL in 1 BOTTLE, PLASTIC 2013/01/01
2 NDC: 11822-3678-7 473mL in 1 BOTTLE 2019/01/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA019125 USA 2019/01/01

Labeler - Rite Aid Corporation( 014578892)

Establishment

Name ID/FEI Business Operations
Rite Aid Corporation 014578892 manufacture( 11822-3678)

Package label and principal display panel

Compare to the active ingredient in Hibiclens

ANTISEPTIC/ANTIMICROBIAL

SKIN CLEANSER

CHLORHEXIDINE GLUCONATE

4% SOLUTION

dye free

for external use only

RITE AID PHARMACY

TAMPER-EVIDENT:

DO NOT USE IF

SHRINK SEAL NECKBAND

IS BROKEN OR MISSING

8 FL OZ (237mL)