SPL v1
SPL
SPL Set ID 3681478e-1e6a-3ed2-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (0.3 g)
Inactive Ingredients
Alcohol Sodium Lauryl Sulfate Sodium Chloride Sodium Xylenesulfonate D&c Red No. 33 Methylchloroisothiazolinone Sodium Laureth Sulfate Water Sodium Dodecylbenzenesulfonate Edetate Sodium Benzisothiazolinone Methylisothiazolinone Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-04-30

Description

Chloroxylenol 0.30%

Purpose

Antibacterial hand soap


Medication Information

Purpose

Antibacterial hand soap

Description

Chloroxylenol 0.30%

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only

Directions

wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Questions?

1-800-776-6702

Active Ingredient

Chloroxylenol 0.30%

Inactive Ingredients:

Water, Sodium Laureth Sulfate, Sodium Dodecybenzenesulfonate, Sodium Chloride, Alcohol Denat., Sodium Xylenesulfonate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Benzisothiazolinone, Methyisothiazolinone, Methylchloroisothiazolinone, Fragrance, FD&C Yellow No. 5, D&C Red No. 33

Back Label Ee Orange.jpg

Keep Out of Reach of Children.

In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.


Structured Label Content

Use

for handwashing to decrease bacteria on the skin

Purpose

Antibacterial hand soap

Warnings

For external use only

Directions

wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Questions?

1-800-776-6702

Active Ingredient

Chloroxylenol 0.30%

Inactive Ingredients:

Water, Sodium Laureth Sulfate, Sodium Dodecybenzenesulfonate, Sodium Chloride, Alcohol Denat., Sodium Xylenesulfonate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Benzisothiazolinone, Methyisothiazolinone, Methylchloroisothiazolinone, Fragrance, FD&C Yellow No. 5, D&C Red No. 33

Back Label Ee Orange.jpg (Back label EE Orange.jpg)

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.


Advanced Ingredient Data


Raw Label Data

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