4% Rite Aid 18oz Fm

4% Rite Aid 18oz Fm
SPL v2
SPL
SPL Set ID bff185e2-b66f-9fa2-e053-2a95a90ab738
Route
TOPICAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorhexidine (4 g)
Inactive Ingredients
Dihydroxyethyl Lauramine Oxide Peg-75 Lanolin Hydroxyethyl Cellulose (2000 Cps At 1%) Water Tridecyl Alcohol Gluconolactone Isopropyl Alcohol Coco Diethanolamide

Identifiers & Packaging

Marketing Status
NDA Active Since 2021-04-14

Description

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chlorhexidine gluconate 4% solution

Uses

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

skin wound and general skin cleansing

Section 43683-2

Uses: removal of surgical handscrub indication (11/23)

Directions: removal of surgical handscurb indication (11/23)

Section 51945-4

Compare to the active ingredient in Hibiclens®*

NDC 11822-0891-2

ANTISEPTIC/ANTIMICROBIAL

SKIN CLEANSER

CHLORHEXIDINE GLUCONATE

4% SOLUTION

dye free

for external use only

TAMPER-EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

18 FL OZ (532 mL)

4RA18FM1061LBLB

*This product is not manufactured or distributed by Molnlycke Healthcare, owner of the registered trademark Hibiclens®.

DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION GUARANTEE: If you’re not satisfied, we’ll happily refund your money.

Section 60561-8

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.

WARNING: CANCER - WWW.P65WARNINGS.CA.GOV

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

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

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

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

Healthcare personnel handwash:

  • wet hands with water
  • dispense 4 full pumps (6 grams) of product into cupped hands and wash in a vigrous manner for 15 seconds
  • rinse and dry thoroughly

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
Do Not Use
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with the meninges
  • in the genital area
Active Ingredient

Chlorhexidine gluconate 4% solution

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

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

Questions Or Comments?

1-800-587-3721

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 ete 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 healthcare provider
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.


Structured Label Content

Uses

healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

skin wound and general skin cleansing

Section 43683-2 (43683-2)

Uses: removal of surgical handscrub indication (11/23)

Directions: removal of surgical handscurb indication (11/23)

Section 51945-4 (51945-4)

Compare to the active ingredient in Hibiclens®*

NDC 11822-0891-2

ANTISEPTIC/ANTIMICROBIAL

SKIN CLEANSER

CHLORHEXIDINE GLUCONATE

4% SOLUTION

dye free

for external use only

TAMPER-EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING

18 FL OZ (532 mL)

4RA18FM1061LBLB

*This product is not manufactured or distributed by Molnlycke Healthcare, owner of the registered trademark Hibiclens®.

DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION GUARANTEE: If you’re not satisfied, we’ll happily refund your money.

Section 60561-8 (60561-8)

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.

WARNING: CANCER - WWW.P65WARNINGS.CA.GOV

Purpose

Antiseptic

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction. Symptoms may include:

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

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

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

Healthcare personnel handwash:

  • wet hands with water
  • dispense 4 full pumps (6 grams) of product into cupped hands and wash in a vigrous manner for 15 seconds
  • rinse and dry thoroughly

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
Do Not Use (Do not use)
  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with the meninges
  • in the genital area
Active Ingredient (Active ingredient)

Chlorhexidine gluconate 4% solution

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-587-3721

When Using This Product (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 ete 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 healthcare provider
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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