Prestige

Prestige
SPL v4
SPL
SPL Set ID 2e4bb97c-9c16-43d1-aea3-54723c7afc45
Route
TOPICAL
Published
Effective Date 2024-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-03
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

Section 50565-1

Not for use on children under 6 months of age.

For institutional and professional use only.

Section 51945-4

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 physician.

Directions
  • Wet hands and forearms.
  • Apply a small amount (5 mL) or palmful to hands and forearms.
  • Scrub thoroughly for at least fifteen seconds.
  • Rinse completely and dry.
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

Section 50565-1 (50565-1)

Not for use on children under 6 months of age.

For institutional and professional use only.

Section 51945-4 (51945-4)

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 physician.

Directions
  • Wet hands and forearms.
  • Apply a small amount (5 mL) or palmful to hands and forearms.
  • Scrub thoroughly for at least fifteen seconds.
  • Rinse completely and dry.
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: 2026-02-15T12:02:53.907272 · Updated: 2026-03-14T23:02:40.652524