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
Purpose

Skin Antimicrobial

Description

Chloroxylenol 1% w/w

Medication Information

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.

Purpose

Skin Antimicrobial

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.
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

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

Active Ingredient

Chloroxylenol 1% w/w

Structured Label Content

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.

Purpose

Skin Antimicrobial

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.
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

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)

Active Ingredient

Chloroxylenol 1% w/w

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:53.907272 · Updated: 2026-03-14T23:02:40.652524