Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 69335c90-5db6-1a43-e053-2991aa0a431c
Route
TOPICAL
Published
Effective Date 2018-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.1 g)
Inactive Ingredients
Sodium Tallowate, Beef Sodium Cocoate Sodium Palm Kernelate Sodium Palmitate Water Glycerin Sodium Chloride Edetate Sodium Fd&c Yellow No. 5 Food Yellow 3 Free Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-05
Description

Chloroxylenol 0.1%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Chloroxylenol 0.1%

Use

■ for hand washing to decrease bacteria on the skin

Warnings

For external use only

Directions

■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

Package Label

Active Ingredient

Chloroxylenol 0.1%

Inactive Ingredients

Sodium Palmate, Sodium Tallowate, Sodium Cocoate, Sodium Palm Kernelate, Water, Glycerin, Fragrance,Sodium Chloride, Tetrasodium EDTA, FD&C Yellow No. 6, FD&C Yellow No. 5

When Using This Product

■ avoid contact with eyes. In case of eye contact, flush with water

Stop Use and Ask A Doctor If

■ irritation and redness develops

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use

■ for hand washing to decrease bacteria on the skin

Purpose

Antibacterial

Warnings

For external use only

Directions

■ wet bar with water ■ lather vigorously and wash skin ■ rinse and dry thoroughly

Package Label

Active Ingredient (Active ingredient)

Chloroxylenol 0.1%

Inactive Ingredients (Inactive ingredients)

Sodium Palmate, Sodium Tallowate, Sodium Cocoate, Sodium Palm Kernelate, Water, Glycerin, Fragrance,Sodium Chloride, Tetrasodium EDTA, FD&C Yellow No. 6, FD&C Yellow No. 5

When Using This Product (When using this product)

■ avoid contact with eyes. In case of eye contact, flush with water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ irritation and redness develops

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:33.027062 · Updated: 2026-03-14T22:55:05.352338