SPL v1
SPL
SPL Set ID 269d99ac-c6e7-4afc-9193-2b7500bd1202
Route
TOPICAL
Published
Effective Date 2010-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (1 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Isopropyl Alcohol Edetate Sodium Citric Acid Monohydrate Lauric Diethanolamide Sodium C14-16 Olefin Sulfonate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-03-04
Description

Active Ingredient Chloroxylenol 1% w/w

Medication Information

Warnings and Precautions
Warnings

For external use only.

Keep out of reach of children.

Avoid contact with eyes and mouth.

If redness or irritation develops, discontinue use immediately.  If condition persists for more than 72 hours, consult a physician.

Not for use on children under 6 months of age.

Indications and Usage
Uses

  • Hand Wash to help reduce bacteria that cause disease
  • Repeated usage suggested
Dosage and Administration
Directions

  • Wash hands and forearms.
  • Apply 5 mL of product to hands.
  • Scrub well for 30 seconds.
  • Rinse and repeat.
Description

Active Ingredient Chloroxylenol 1% w/w

Section 51727-6
Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene Acrylates/Copolymer, Tetrasodium EDTA, Citric Acid

Section 51945-4
Section 53413-1
In Case of Emergency

Call: (800) 228-5635  ext. 167

Section 55105-1
Purpose

Health Care Personnel Hand Wash

Section 55106-9
Active Ingredient

Chloroxylenol 1% w/w

Structured Label Content

Indications and Usage (34067-9)
Uses

  • Hand Wash to help reduce bacteria that cause disease
  • Repeated usage suggested
Dosage and Administration (34068-7)
Directions

  • Wash hands and forearms.
  • Apply 5 mL of product to hands.
  • Scrub well for 30 seconds.
  • Rinse and repeat.
Warnings and Precautions (34071-1)
Warnings

For external use only.

Keep out of reach of children.

Avoid contact with eyes and mouth.

If redness or irritation develops, discontinue use immediately.  If condition persists for more than 72 hours, consult a physician.

Not for use on children under 6 months of age.

Section 51727-6 (51727-6)
Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene Acrylates/Copolymer, Tetrasodium EDTA, Citric Acid

Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
In Case of Emergency

Call: (800) 228-5635  ext. 167

Section 55105-1 (55105-1)
Purpose

Health Care Personnel Hand Wash

Section 55106-9 (55106-9)
Active Ingredient

Chloroxylenol 1% w/w

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:03.241402 · Updated: 2026-03-14T22:52:22.069763