Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2c0fd9af-f64c-45c6-8ff7-f16e13145d96
Route
TOPICAL
Published
Effective Date 2010-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (0.5 mL)
Inactive Ingredients
Water Propylene Glycol Trolamine Lauryl Sulfate Sodium Laureth Sulfate Aloe Vera Leaf Cocamidopropyl Betaine Allantoin Edetate Sodium Diazolidinyl Urea Citric Acid Monohydrate Methylparaben Magnesium Nitrate Propylparaben Methylchloroisothiazolinone Magnesium Chloride Methylisothiazolinone

Identifiers & Packaging

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

Description

Active ingredient Chloroxylenol, 0.5%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For handwashing to reduce bacteria on the skin

Dosage and Administration

Directions

Apply foaming cleanser to dry hands

Rub hands together to spead lather

Wash for 15-20 seconds

Rinse and dry hands thoroughly

Description

Active ingredient Chloroxylenol, 0.5%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

Section 51727-6

Inactive ingredients

Water, Propylene Glycol, TEA-Lauryl Sulfate, PPG-24-Glycereth-24, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Allantoin, Fragrance, Tetrasodium EDTA, Diazolidinyl Urea, Citric Acid, Methylparaben, Magnesium Nitrate, Propylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

Section 51945-4

deb

PureBac Foam Wash

MADE IN USA

1L

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active ingredient

Chloroxylenol, 0.5%


Structured Label Content

Indications and Usage (34067-9)

Uses

For handwashing to reduce bacteria on the skin

Dosage and Administration (34068-7)

Directions

Apply foaming cleanser to dry hands

Rub hands together to spead lather

Wash for 15-20 seconds

Rinse and dry hands thoroughly

Warnings and Precautions (34071-1)

Warnings

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.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

Section 51727-6 (51727-6)

Inactive ingredients

Water, Propylene Glycol, TEA-Lauryl Sulfate, PPG-24-Glycereth-24, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Allantoin, Fragrance, Tetrasodium EDTA, Diazolidinyl Urea, Citric Acid, Methylparaben, Magnesium Nitrate, Propylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

Section 51945-4 (51945-4)

deb

PureBac Foam Wash

MADE IN USA

1L

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Chloroxylenol, 0.5%


Advanced Ingredient Data


Raw Label Data

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