ec0be0b0-92bd-8ada-e053-2995a90a55c6

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
Purpose

Antiseptic

Description

Chloroxylenol 0.1%

Medication Information

Warnings

For external use only.

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

Uses

Handwash to help decrease bacteria on the skin.

Purpose

Antiseptic

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.
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).

Description

Chloroxylenol 0.1%

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

Active Ingredient

Chloroxylenol 0.1%

Structured Label Content

Warnings

For external use only.

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

Uses

Handwash to help decrease bacteria on the skin.

Purpose

Antiseptic

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.
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).

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)

Active Ingredient

Chloroxylenol 0.1%

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