SPL v8
SPL
SPL Set ID b0a70513-9530-4209-90c9-3cf2fd9895e5
Route
TOPICAL
Published
Effective Date 2020-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (10 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Sodium Laureth Sulfate Lauric Diethanolamide Isopropyl Alcohol Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-20
Description

Chloroxylenol 1% w/w

Purpose

Skin antimicrobial

Medication Information

Purpose

Skin antimicrobial

Description

Chloroxylenol 1% w/w

Use

Reduces amount of bacteria on hands.

Warnings
  • For external use only.  Do not use in eyes.
  • Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours consult a doctor.
  • Not for use on children under six months of age.
  • For institutional and professional use only.
Directions
  • Wet hands and forearms.
  • Apply a small amount (5 mL) or palmful to hands and forearms.
  • Scrub thoroughly for at least 15 seconds.
  • Rinse completely and dry.
questions?

1-800-537-8990

package Label

Active Ingredient

Chloroxylenol 1% w/w

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

Structured Label Content

Use

Reduces amount of bacteria on hands.

Purpose

Skin antimicrobial

Warnings
  • For external use only.  Do not use in eyes.
  • Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours consult a doctor.
  • Not for use on children under six months of age.
  • For institutional and professional use only.
Directions
  • Wet hands and forearms.
  • Apply a small amount (5 mL) or palmful to hands and forearms.
  • Scrub thoroughly for at least 15 seconds.
  • Rinse completely and dry.
questions? (Questions?)

1-800-537-8990

package Label (Package Label)

Active Ingredient

Chloroxylenol 1% w/w

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:58.711599 · Updated: 2026-03-14T23:12:56.390264