SPL v3
SPL
SPL Set ID 203d01ae-d99e-bce3-e063-6294a90a1a2d
Route
TOPICAL
Published
Effective Date 2024-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (4 mg) Chlorhexidine (10 mg)
Inactive Ingredients
Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-22

Description

benzalkonium chloride ,chlorhexidine


Medication Information

Warnings and Precautions

*For extemal use only.

*Flammable. keep away from fire or flame.

Indications and Usage

For Daily cleaning and disinfecting care wipe for human skin or object surface.

Dosage and Administration

For Daily cleaning and disinfecting care wipe for human skin or object surface.One piece at a time.

Description

benzalkonium chloride ,chlorhexidine

Section 44425-7

Store at room temperature.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

*Stop use if irritation and redness develop. If condition persists consult your health care practioner.

*Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1

Do not use " with electrocautery procedures " in the eyes. lf contact occurs, flush eyes with water.

Section 51727-6

water,phenoxyethanol

Section 51945-4

Section 55105-1

disinfect

Section 55106-9

benzalkonium chloride ,chlorhexidine


Structured Label Content

Indications and Usage (34067-9)

For Daily cleaning and disinfecting care wipe for human skin or object surface.

Dosage and Administration (34068-7)

For Daily cleaning and disinfecting care wipe for human skin or object surface.One piece at a time.

Warnings and Precautions (34071-1)

*For extemal use only.

*Flammable. keep away from fire or flame.

Section 44425-7 (44425-7)

Store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

*Stop use if irritation and redness develop. If condition persists consult your health care practioner.

*Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Section 50570-1 (50570-1)

Do not use " with electrocautery procedures " in the eyes. lf contact occurs, flush eyes with water.

Section 51727-6 (51727-6)

water,phenoxyethanol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

disinfect

Section 55106-9 (55106-9)

benzalkonium chloride ,chlorhexidine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)