SPL v4
SPL
SPL Set ID 25692dd8-1a8d-48db-b6bd-b46c58ce52fb
Route
TOPICAL
Published
Effective Date 2013-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (0.1 g)
Inactive Ingredients
Water Urea Sodium Dodecylbenzenesulfonate Sodium Laureth Sulfate Alcohol Magnesium Chloride Lauramine Oxide Disodium 2-sulfopalmitate Methyl Palmitate Sodium Metabisulfite Edetate Sodium Methylchloroisothiazolinone Methylisothiazolinone Sulisobenzone Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-01-01

Description

Active ingredient Triclosan 0.10%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Use helps fight germs on hands when used as a hand soap

Dosage and Administration

Directions wash hands and rinse

Description

Active ingredient Triclosan 0.10%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. In case of eye contact, rinse thoroughly with water.

Section 51727-6

Inactive ingredients Water, Urea, Sodium Laureth Sulfate, Sodium Dodecylbenzenesulfonate, Alcohol Denat., Lauramine Oxide, Magnesium Chloride, Sodium Methyl 2-Sulfopalmitate, Fragrance, Sodium Metabisulfite, Disodium 2-Sulfopalmitate, Methyl Palmitate, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Yellow No. 5, Blue No.1

Section 51945-4

LBLFR

LBLBK

Section 53413-1

Questions? call 1-800-910-6874

Section 55105-1

Antibacterial hand soap

Section 55106-9

Active ingredient

Triclosan 0.10%


Structured Label Content

Indications and Usage (34067-9)

Use helps fight germs on hands when used as a hand soap

Dosage and Administration (34068-7)

Directions wash hands and rinse

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. In case of eye contact, rinse thoroughly with water.

Section 51727-6 (51727-6)

Inactive ingredients Water, Urea, Sodium Laureth Sulfate, Sodium Dodecylbenzenesulfonate, Alcohol Denat., Lauramine Oxide, Magnesium Chloride, Sodium Methyl 2-Sulfopalmitate, Fragrance, Sodium Metabisulfite, Disodium 2-Sulfopalmitate, Methyl Palmitate, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4, Yellow No. 5, Blue No.1

Section 51945-4 (51945-4)

LBLFR

LBLBK

Section 53413-1 (53413-1)

Questions? call 1-800-910-6874

Section 55105-1 (55105-1)

Antibacterial hand soap

Section 55106-9 (55106-9)

Active ingredient

Triclosan 0.10%


Advanced Ingredient Data


Raw Label Data

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