77955-004

77955-004
SPL v4
SPL
SPL Set ID b9492b5a-9097-4f3c-e053-2a95a90a6650
Route
TOPICAL
Published
Effective Date 2021-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.01 mg)
Inactive Ingredients
Water Propylene Glycol Ammonium Laureth-3 Sulfate Sodium Chloride Glycerin Citric Acid Monohydrate Ammonium Lauryl Sulfate Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-19
Description

Chloroxylenol 1%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Chloroxylenol 1%

Uses
  • For handwashing to decrease bacteria on the skin that could cause disease
  • Recommended for repeated use
Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctorif irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this productavoid contact with eyes.

In case of contact, flush eyes with water.

Section 51945-4

ANTIBACTERIAL GEL SOAP

(NSF E2 Registered)

UniFirst Corporation #88UI 1L(1000ml., 33.8 US fl. oz)

Warnings

For external use only: hands

Directions:

Wet hands

Apply product and work into a lather.

Rinse well with potable water and dry hands thoroughly.

Active Ingredients

Chloroxylenol 1%

Inactive Ingredients:

Water, Propylene glycol, Ammonium Lauryl sulfate, Ammonium laureth sulfate, Tetrasodium EDTA, Sodium chloride, Glycerin, Citric acid.

Structured Label Content

Uses
  • For handwashing to decrease bacteria on the skin that could cause disease
  • Recommended for repeated use
Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctorif irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this productavoid contact with eyes.

In case of contact, flush eyes with water.

Section 51945-4 (51945-4)

ANTIBACTERIAL GEL SOAP

(NSF E2 Registered)

UniFirst Corporation #88UI 1L(1000ml., 33.8 US fl. oz)

Purpose

Antimicrobial

Warnings

For external use only: hands

Directions:

Wet hands

Apply product and work into a lather.

Rinse well with potable water and dry hands thoroughly.

Active Ingredients (Active ingredients)

Chloroxylenol 1%

Inactive Ingredients: (Inactive ingredients:)

Water, Propylene glycol, Ammonium Lauryl sulfate, Ammonium laureth sulfate, Tetrasodium EDTA, Sodium chloride, Glycerin, Citric acid.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:15.614360 · Updated: 2026-03-14T23:12:25.780176