Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9e39192e-fcf1-416b-ad3d-cf3d1a44a7a4
Route
TOPICAL
Published
Effective Date 2010-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triclosan (0.15 mL)
Inactive Ingredients
Water Sodium Laureth Sulfate Coco Diethanolamide Propylene Glycol Sodium Chloride Chloroxylenol Edetate Sodium Anhydrous Citric Acid Sodium Hydroxide Fd&c Yellow No. 5 D&c Red No. 33 Methylchloroisothiazolinone Methylisothiazolinone Magnesium Nitrate Magnesium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-01-01

Description

Active Ingredient Triclosan, 0.15%


Medication Information

Warnings and Precautions

Warnings

For external use only

Avoid contact with the eyes

Indications and Usage

Uses

For handwashing to reduce bacteria on the skin

Dosage and Administration

Directions

Wet hands

Apply small amount of soap and work into lather

Wash for 15 to 20 seconds

Rinse completely

Dry hands thoroughly

Description

Active Ingredient Triclosan, 0.15%

Section 50565-1

Keep out of reach of children

Consult a physician or poison control center if ingested

Section 51727-6

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamide DEA, Propylene Glycol, Sodium Chloride, Chloroxylenol. Acrylic Copolymer, Tetrasodium EDTA, Citric Acid, Fragrance, Sodium Hydroxide, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Yellow 5 (C! 19140), Red 33 (CI 17200).

Section 51945-4

DEB

GOLD

Antibacterial Lotion Soap with Moisturizers

Cleans hands!

Kills germs!

Moisturizes skin!

One Gallon 3.78 Liters

76105-01-116

MADE IN U.S.A.

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Triclosan, 0.15%


Structured Label Content

Indications and Usage (34067-9)

Uses

For handwashing to reduce bacteria on the skin

Dosage and Administration (34068-7)

Directions

Wet hands

Apply small amount of soap and work into lather

Wash for 15 to 20 seconds

Rinse completely

Dry hands thoroughly

Warnings and Precautions (34071-1)

Warnings

For external use only

Avoid contact with the eyes

Section 50565-1 (50565-1)

Keep out of reach of children

Consult a physician or poison control center if ingested

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Sodium Laureth Sulfate, Cocamide DEA, Propylene Glycol, Sodium Chloride, Chloroxylenol. Acrylic Copolymer, Tetrasodium EDTA, Citric Acid, Fragrance, Sodium Hydroxide, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Yellow 5 (C! 19140), Red 33 (CI 17200).

Section 51945-4 (51945-4)

DEB

GOLD

Antibacterial Lotion Soap with Moisturizers

Cleans hands!

Kills germs!

Moisturizes skin!

One Gallon 3.78 Liters

76105-01-116

MADE IN U.S.A.

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Triclosan, 0.15%


Advanced Ingredient Data


Raw Label Data

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