SPL v1
SPL
SPL Set ID ba54aab6-88a2-4886-a33f-a67d3a4a4631
Route
TOPICAL
Published
Effective Date 2014-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (0.1 g)
Inactive Ingredients
Water Urea Sodium Laureth Sulfate Sodium Dodecylbenzenesulfonate Alcohol Lauramine Oxide Magnesium Chloride Sodium Metabisulfite Disodium 2-sulfopalmitate Methyl Palmitate Edetate Sodium Methylchloroisothiazolinone Methylisothiazolinone Sulisobenzone Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-07-01

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, FD&C Yellow No. 5, D&C Red No. 33

Section 51945-4

LBLFR

LBLBK

Section 53413-1

Questions? 1-800-Wegmans (934-6267) Ext 5920 9am-4pm EST workdays

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, FD&C Yellow No. 5, D&C Red No. 33

Section 51945-4 (51945-4)

LBLFR

LBLBK

Section 53413-1 (53413-1)

Questions? 1-800-Wegmans (934-6267) Ext 5920 9am-4pm EST workdays

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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