SPL v1
SPL
SPL Set ID a746f7a6-72e5-469a-e053-2995a90a90a3
Route
TOPICAL
Published
Effective Date 2020-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.6 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Edetate Sodium Propylene Glycol Sodium Chloride Boric Acid Peg-75 Lanolin Dmdm Hydantoin Sodium Lauryl Sulfate Glycol Stearate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-04
Description

PCMX (para-chloro-meta-xylenol) 0.6%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

PCMX (para-chloro-meta-xylenol) 0.6%

Use

for handwashing to decrease bacteria on skin

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 doctor if

  • irritation and redness develop.
Section 50567-7

When using this product:

  • Do not get in eyes.
  • If contact occurs, rinse eyes thoroughly with water.
Section 51945-4

Hu-Friedy

HAND ESSENTIALS

ANTIBACTERIAL SOAP

Effective against a broad

spectrum of activity

against gram negative and

gram positive bacteria.

Contains emollients to

help moisten skin and

maintain its natural oils.

473 ml/16.0 FL. OZ.

NDC: 65626-018-16

Manufactured for:

Hu-Friedy Nfg. Co., LLC

3232 N. Rockwell St. Chicago, IL 60618

1-800-Hu-Friedy Hu-Friedy.com

MADE IN USA

Hu-Friedy

Warnings

For external use only.

Directions
  • Ready to use.
  • Do not dilute.
  • Wet hands and forearms.
  • Apply 5 ml (tsp) or palmful to hands and forearms.
  • Scrub thoroughly for 1 minute and rinse.
Active Ingredient

PCMX (para-chloro-meta-xylenol) 0.6%

Inert Ingredients

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Tetrasodium EDTA, Propylene Glycol, Fragrance, Sodium Chloride, Boric Acid, Glycol Stearate, PEG-75 Lanolin, DMDM Hydantoin, Aloe Vera.

Structured Label Content

Use

for handwashing to decrease bacteria on skin

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 doctor if

  • irritation and redness develop.
Section 50567-7 (50567-7)

When using this product:

  • Do not get in eyes.
  • If contact occurs, rinse eyes thoroughly with water.
Section 51945-4 (51945-4)

Hu-Friedy

HAND ESSENTIALS

ANTIBACTERIAL SOAP

Effective against a broad

spectrum of activity

against gram negative and

gram positive bacteria.

Contains emollients to

help moisten skin and

maintain its natural oils.

473 ml/16.0 FL. OZ.

NDC: 65626-018-16

Manufactured for:

Hu-Friedy Nfg. Co., LLC

3232 N. Rockwell St. Chicago, IL 60618

1-800-Hu-Friedy Hu-Friedy.com

MADE IN USA

Hu-Friedy

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Ready to use.
  • Do not dilute.
  • Wet hands and forearms.
  • Apply 5 ml (tsp) or palmful to hands and forearms.
  • Scrub thoroughly for 1 minute and rinse.
Active Ingredient (Active ingredient)

PCMX (para-chloro-meta-xylenol) 0.6%

Inert Ingredients (Inert ingredients)

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Tetrasodium EDTA, Propylene Glycol, Fragrance, Sodium Chloride, Boric Acid, Glycol Stearate, PEG-75 Lanolin, DMDM Hydantoin, Aloe Vera.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:49.886210 · Updated: 2026-03-14T22:57:06.397974