cef33d1e-bc34-3c3d-e053-2995a90aeef2

SPL v5
SPL
SPL Set ID cef33d1e-bc34-3c3d-e053-2995a90aeef2
Route
topical
Published
Effective Date 2025-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chloroxylenol (2.5 g)
Inactive Ingredients
tetraiodofluorescein 2-bromo-2-nitropropane-1,3-diol cocamidopropyl hydroxysultaine methylchloroisothiazolinone propylene glycol methylisothiazolinone water propanediol fragrance 13576 sodium chloride sodium lauryl sulfate sodium polyitaconate (2800 mw, phosphate terminated) sodium c14-16 olefin sulfonate glycol distearate

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph drug active Since 2021-12-02
Purpose

Antiseptic

Description

Chloroxylenol 0.25%.

Medication Information

Uses

Handwash to help decrease bacteria on the skin

Purpose

Antiseptic

Directions

• Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.

• Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water (aqua) (7732-18-5), Sodium Lauryl Sulfate (68585-47-7), Cocamidopropyl Hydroxysultaine (68139-30-0), Propylene Glycol (57-55-6), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Sodium C14-16 Olefin Sulfonate (68439-57-6), Glycol Distearate (627-83-8), Fragance (Proprietary), Sodium Polyitaconate (26099-89-8), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Acid Red 51 (16423-68-0).

Description

Chloroxylenol 0.25%.

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 doctor if irritation or rash appears and lasts.

Section 51945-4

Warning:

For external use only

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

Active Ingredient

Chloroxylenol 0.25%.

Structured Label Content

Uses

Handwash to help decrease bacteria on the skin

Purpose

Antiseptic

Directions

• Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.

• Children under 6 years of age should be supervised when using this product.

Inactive Ingredients (Inactive ingredients)

Water (aqua) (7732-18-5), Sodium Lauryl Sulfate (68585-47-7), Cocamidopropyl Hydroxysultaine (68139-30-0), Propylene Glycol (57-55-6), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Sodium C14-16 Olefin Sulfonate (68439-57-6), Glycol Distearate (627-83-8), Fragance (Proprietary), Sodium Polyitaconate (26099-89-8), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Acid Red 51 (16423-68-0).

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 doctor if irritation or rash appears and lasts.

Section 51945-4 (51945-4)

Warning:

For external use only

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

Active Ingredient

Chloroxylenol 0.25%.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:03.756375 · Updated: 2026-03-14T23:10:14.816739