Drug Facts 5900-127

Drug Facts 5900-127
SPL v2
SPL
SPL Set ID ac49f166-beba-4a9d-86c1-15f016a26665
Route
TOPICAL
Published
Effective Date 2019-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (10 mg)
Inactive Ingredients
Water Potassium Cocoate Edetate Sodium Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-15
Description

Active ingredient Chloroxylenol 1.0%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • handwash to help reduce bacteria that potentially can cause disease
  • helps to prevent cross-contamination by hand contact
  • helps to prevent drying of the skin
  • recommended for repeated use

Dosage and Administration

Directions

  • wet hands and wrists with clean, running water
  • apply appropriate amount of product
  • lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds
  • rinse thoroughly with running water
  • dry hands completely (incomplete drying may result in chapped skin)

Description

Active ingredient Chloroxylenol 1.0%

Section 44425-7

Other information

store in a cool, dry place below 104 oF (40 oC)

Section 50565-1

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor ifirritation and redness develop.

Section 50567-7

When using this product

do not use in or near eyes

Section 51727-6

Inactive ingredients

Water, potassium cocoate, fragrance, tetrasodium EDTA, FDC Blue 1, FDC Yellow 5

Section 51945-4

versaclenz compatible

SoftenSure

foam soap

antimicrobial

BEST

SANITIZERS

INC.

Net Contents:

Section 53413-1

Questions?

Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4pm PST

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Chloroxylenol 1.0%

Structured Label Content

Indications and Usage (34067-9)

Uses

  • handwash to help reduce bacteria that potentially can cause disease
  • helps to prevent cross-contamination by hand contact
  • helps to prevent drying of the skin
  • recommended for repeated use

Dosage and Administration (34068-7)

Directions

  • wet hands and wrists with clean, running water
  • apply appropriate amount of product
  • lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds
  • rinse thoroughly with running water
  • dry hands completely (incomplete drying may result in chapped skin)

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

store in a cool, dry place below 104 oF (40 oC)

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, seek medical attention or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifirritation and redness develop.

Section 50567-7 (50567-7)

When using this product

do not use in or near eyes

Section 51727-6 (51727-6)

Inactive ingredients

Water, potassium cocoate, fragrance, tetrasodium EDTA, FDC Blue 1, FDC Yellow 5

Section 51945-4 (51945-4)

versaclenz compatible

SoftenSure

foam soap

antimicrobial

BEST

SANITIZERS

INC.

Net Contents:

Section 53413-1 (53413-1)

Questions?

Contact Best Sanitizers at 888-225-3267 Mon-Fri 9am - 4pm PST

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Chloroxylenol 1.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:51.247122 · Updated: 2026-03-14T23:05:56.026643