SPL v1
SPL
SPL Set ID d1ab46dd-0d09-4197-9ea1-d908dc6b08cb
Route
TOPICAL
Published
Effective Date 2013-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (1.5 mg)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Sodium Laureth Sulfate Coco Diethanolamide Sodium Chloride Peg-150 Distearate Citric Acid Monohydrate Glycerin Edetate Disodium .alpha.-tocopherol Acetate Methylchloroisothiazolinone Fd&c Yellow No. 5 Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-08
Description

Active Ingredient                                   Purpose Triclosan 0.15%..................................Antibacterial

Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this productl, avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor, if irritation or redness develops

Indications and Usage

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Dosage and Administration

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Description

Active Ingredient                                   Purpose Triclosan 0.15%..................................Antibacterial

Section 50565-1

Keep away from children, except of under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

Section 51945-4

Section 55105-1

Uses

for handwashing to eliminate bacteria and germs on the skin.

Section 55106-9

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

Structured Label Content

Indications and Usage (34067-9)

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Dosage and Administration (34068-7)

Wet hand, apply palmful to hands, scrub thoroughly, Rinse.

Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this productl, avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor, if irritation or redness develops

Section 50565-1 (50565-1)

Keep away from children, except of under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water, cocamide MEA, PEG-18 glycaryl

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

for handwashing to eliminate bacteria and germs on the skin.

Section 55106-9 (55106-9)

Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.953870 · Updated: 2026-03-14T22:53:33.698024