drug facts ndc 64536-8308

SPL v8

SPL

SPL Set ID 801f07c1-6eea-4929-bb27-5768efe5de65

Route

topical

Published

Effective Date 2023-12-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

chloroxylenol (1 g)

Inactive Ingredients

alcohol propylene glycol ammonium lauryl sulfate isopropyl alcohol edetate sodium sodium laureth-3 sulfate water

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2016-07-01 Until 2018-12-22

Description

Active ingredient Chloroxylenol 1.0%

Medication Information

Warnings and Precautions

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not ingest.

Active Ingredient

Active ingredient

Chloroxylenol 1.0%

Indications and Usage

Uses

For handwashing to decrease bacteria on the skin.

For occasional use.

Dosage and Administration

Directions

Wet hands and forearms.

Apply 0.4 mL or 1.0 mL of soap to hands.

Lather hands and forearms for at least 30 seconds, rinse thoroughly with potable water.

Supervise children when they use this product.

Description

Active ingredient Chloroxylenol 1.0%

Section 34093-5

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0301548

FOR COMMERCIAL USE.

See container for Lot Code and Expiry Date.

Store in a cool dry place.

Section 50565-1

Keep out of reach of children.

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

Do not use if you are allergic to any ingredients

Section 50566-9

Stop use and ask a doctor if irritation and redness develop.

If condition persists for more than 72 hours consult a doctor.

Section 50567-7

When using this product do not get into eyes.

In case of eye contact, immediately flush with water.

Section 50570-1

Do not use in the eyes.

Section 51727-6

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Alcohol Denat, Sodium Lauryl Ether Sulfate, Propylene Glycol, Tetrasodium EDTA, Isopropyl Alcohol

Section 51945-4

NDC 64536-8308-3

DIN 02448866

Diversey

SoftCare Defend Foam

Antibacterial Handwash

Chloroxylenol Liquid

For commercial use

NSF

Nonfood Compounds

Program listed E2

Registration # 152964

(L) Exp.

Net Contents

1.2 L/ 1.27 U.S. Qt.

SKU: 100907902

Section 53413-1

Questions or comments?

1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time

www.diversey.com

Section 55105-1

Purpose

Antiseptic

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not ingest.

Active Ingredient (55106-9)

Active ingredient

Chloroxylenol 1.0%

Indications and Usage (34067-9)

Uses

For handwashing to decrease bacteria on the skin.

For occasional use.

Dosage and Administration (34068-7)

Directions

Wet hands and forearms.

Apply 0.4 mL or 1.0 mL of soap to hands.

Lather hands and forearms for at least 30 seconds, rinse thoroughly with potable water.

Supervise children when they use this product.

Section 34093-5 (34093-5)

Other information

EMERGENCY PHONE: 1-800-851-7145

See SDS MS0301548

FOR COMMERCIAL USE.

See container for Lot Code and Expiry Date.

Store in a cool dry place.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Do not use if you are allergic to any ingredients

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop.

If condition persists for more than 72 hours consult a doctor.

Section 50567-7 (50567-7)

When using this product do not get into eyes.

In case of eye contact, immediately flush with water.

Section 50570-1 (50570-1)

Do not use in the eyes.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Alcohol Denat, Sodium Lauryl Ether Sulfate, Propylene Glycol, Tetrasodium EDTA, Isopropyl Alcohol

Section 51945-4 (51945-4)

NDC 64536-8308-3

DIN 02448866

Diversey

SoftCare Defend Foam

Antibacterial Handwash

Chloroxylenol Liquid

For commercial use

NSF

Nonfood Compounds

Program listed E2

Registration # 152964

(L) Exp.

Net Contents

1.2 L/ 1.27 U.S. Qt.

SKU: 100907902

Section 53413-1 (53413-1)

Questions or comments?

1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time

www.diversey.com

Section 55105-1 (55105-1)

Purpose

Antiseptic

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIUM LAURYL SULFATE", "unii": "Q7AO2R1M0B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE SODIUM", "unii": "MP1J8420LU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURETH-3 SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROXYLENOL", "unii": "0F32U78V2Q", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses For handwashing to decrease bacteria on the skin. For occasional use.", "34068-7": "Directions Wet hands and forearms. Apply 0.4 mL or 1.0 mL of soap to hands. Lather hands and forearms for at least 30 seconds, rinse thoroughly with potable water. Supervise children when they use this product.", "34071-1": "Warnings Flammable. Keep away from fire or flame. For external use only. Do not ingest.", "34093-5": "Other information EMERGENCY PHONE: 1-800-851-7145 See SDS MS0301548 FOR COMMERCIAL USE. See container for Lot Code and Expiry Date. Store in a cool dry place.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away. Do not use if you are allergic to any ingredients", "50566-9": "Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.", "50567-7": "When using this product do not get into eyes. In case of eye contact, immediately flush with water.", "50570-1": "Do not use in the eyes.", "51727-6": "Inactive ingredients Water, Ammonium Lauryl Sulfate, Alcohol Denat, Sodium Lauryl Ether Sulfate, Propylene Glycol, Tetrasodium EDTA, Isopropyl Alcohol", "51945-4": "NDC 64536-8308-3 DIN 02448866 Diversey SoftCare Defend Foam Antibacterial Handwash Chloroxylenol Liquid For commercial use NSF Nonfood Compounds Program listed E2 Registration # 152964 (L) Exp. U Net Contents 1.2 L/ 1.27 U.S. Qt. SKU: 100907902", "53413-1": "Questions or comments? 1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time www.diversey.com", "55105-1": "Purpose Antiseptic", "55106-9": "Active ingredient Chloroxylenol 1.0%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:30.380498 · Updated: 2026-03-14T23:02:06.847821