SPL v6
SPL
SPL Set ID c9741804-8c98-f851-e053-2995a90aa6f0
Route
TOPICAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (1 g)
Inactive Ingredients
Sodium Lauryl Sulfate Sodium C14-16 Olefin Sulfonate Propanediol Bronopol Propylene Glycol Methylchloroisothiazolinone Methylisothiazolinone Water Cocamidopropyl Hydroxysultaine Glycol Distearate Sodium Citrate Sodium Chloride

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-13

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

Aqua (7732-18-5), Sodium Lauryl Sulfate (68585-47-7), Cocamidopropyl Hydroxysultaine (68139-30-0), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium C14-16 Olefin Sulfonate (68439-57-6), Glycol Distearate (627-83-8), Fragrance (Proprietary), Sodium Citrate (6132-04-3), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7).


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

Aqua (7732-18-5), Sodium Lauryl Sulfate (68585-47-7), Cocamidopropyl Hydroxysultaine (68139-30-0), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium C14-16 Olefin Sulfonate (68439-57-6), Glycol Distearate (627-83-8), Fragrance (Proprietary), Sodium Citrate (6132-04-3), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7).


Advanced Ingredient Data


Raw Label Data

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