SPL v4
SPL
SPL Set ID 4bcc5b97-ef27-4f86-bf3e-bed1511207fc
Route
TOPICAL
Published
Effective Date 2016-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.3 g)
Inactive Ingredients
Sodium Dodecylbenzenesulfonate Sodium Chloride Fd&c Blue No. 1 Edetate Sodium Sodium Xylenesulfonate Sodium Laureth Sulfate Benzisothiazolinone Water Fd&c Yellow No. 5 Sodium Lauryl Sulfate Methylisothiazolinone Alcohol Methylchloroisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-12-30
Description

Active ingredient Chloroxylenol 0.30%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Use for handwashing to decrease bacteria on the skin

Dosage and Administration

Directions wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Description

Active ingredient Chloroxylenol 0.30%

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

Section 51727-6

Inactive ingredients Water, Sodium Laureth Sulfate, Sodium Dodecylbenzenesulfonate, Sodium Chloride, Alcohol Denat., Sodium Xylenesulfonate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Benzisothiazolinone, Methylisothiazolinone, Methylchloroisothiazolinone, Fragrance, FD&C Yellow No. 5, FD&C Blue No. 1

Section 51945-4

Section 53413-1

Questions? 1-877-505-2267

Section 55105-1

Antibacterial hand soap

Section 55106-9

Active ingredient

Chloroxylenol 0.30%

Structured Label Content

Indications and Usage (34067-9)

Use for handwashing to decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

Section 51727-6 (51727-6)

Inactive ingredients Water, Sodium Laureth Sulfate, Sodium Dodecylbenzenesulfonate, Sodium Chloride, Alcohol Denat., Sodium Xylenesulfonate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Benzisothiazolinone, Methylisothiazolinone, Methylchloroisothiazolinone, Fragrance, FD&C Yellow No. 5, FD&C Blue No. 1

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-877-505-2267

Section 55105-1 (55105-1)

Antibacterial hand soap

Section 55106-9 (55106-9)

Active ingredient

Chloroxylenol 0.30%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:16.712810 · Updated: 2026-03-14T22:54:39.402137