SPL v6
SPL
SPL Set ID ec0be0b0-92bd-8ada-e053-2995a90a55c6
Route
TOPICAL
Published
Effective Date 2025-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (1 g)
Inactive Ingredients
Cocamidopropyl Hydroxysultaine Sodium Chloride Sodium Polyitaconate (2800 Mw, Phosphate Terminated) Propanediol Water Fd&c Red No. 40 Fd&c Yellow No. 5 Methylisothiazolinone Methylchloroisothiazolinone Propylene Glycol Bronopol Sodium C14-16 Olefin Sulfonate

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-27
Description

Chloroxylenol 0.1%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Chloroxylenol 0.1%

Uses

Handwash to help decrease bacteria on the skin.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51945-4

Warnings

For external use only.

Do not use in the eyes. In case of contact, immediately flush eyes with water.

Directions
  • Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Chloroxylenol 0.1%

Inactive Ingredients

Water (Aqua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (68439-57-6), Cocamidopropyl Hydroxysultaine (68139-30-0), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium Polyitaconate (26099-89-8), Fragrance (Proprietary), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), Yellow 5 (1934-21-0), Red 40 (25956-17-6).

Structured Label Content

Uses

Handwash to help decrease bacteria on the 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 50569-3 (50569-3)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only.

Do not use in the eyes. In case of contact, immediately flush eyes with water.

Directions
  • Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Chloroxylenol 0.1%

Inactive Ingredients

Water (Aqua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (68439-57-6), Cocamidopropyl Hydroxysultaine (68139-30-0), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium Polyitaconate (26099-89-8), Fragrance (Proprietary), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), Yellow 5 (1934-21-0), Red 40 (25956-17-6).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:43.320725 · Updated: 2026-03-14T23:09:39.646164