SPL v6
SPL
SPL Set ID 4e50f10b-db76-4a53-8ba1-f60da719d0b7
Route
TOPICAL
Published
Effective Date 2021-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (10.11 g)
Inactive Ingredients
Cetrimonium Chloride Water Cocamine Glycerin Lactic Acid, L- Peg-120 Methyl Glucose Dioleate Coco Diisopropanolamide Trisodium Dicarboxymethyl Alaninate, L- D&c Green No. 8 .alpha.-tocopherol Acetate Aloe Vera Leaf Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-05

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses
  • Healthcare personnel hand wash for hand washing to decrease bacteria on the skin before and after contact with a person under medical care or treatment.
  • Recommended for repeated use.
Section 42229-5

Drug Facts

Section 50566-9

Stop use and ask doctor if irritation and redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Warnings
  • For external use only
Directions
  • Wet hands and forearms.
  • Pump enough foam into your palm to thoroughly cover your hands.
  • Scrub thoroughly for at least 20 seconds.
  • Rinse well and dry hands completely.
Questions?

1-800-537-8990

Active Ingredients

Chloroxylenol 1.0%

Inactive Ingredients

Water, Cetrimonium Chloride, Cocamine, Glycerin, Lactic Acid, PEG-120 Methyl Glucose Dioleate, Coco Diisopropanolamide, Fragrance, Trisodium Dicarboxymethyl Alaninate, D&C Green No. 8, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, FD&C Blue No. 1

Keep Out of Reach of Children.

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

Principal Display Panel 3.79 Liters Container Label


Structured Label Content

Uses
  • Healthcare personnel hand wash for hand washing to decrease bacteria on the skin before and after contact with a person under medical care or treatment.
  • Recommended for repeated use.
Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

Stop use and ask doctor if irritation and redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Purpose

Antiseptic

Warnings
  • For external use only
Directions
  • Wet hands and forearms.
  • Pump enough foam into your palm to thoroughly cover your hands.
  • Scrub thoroughly for at least 20 seconds.
  • Rinse well and dry hands completely.
Questions?

1-800-537-8990

Active Ingredients

Chloroxylenol 1.0%

Inactive Ingredients

Water, Cetrimonium Chloride, Cocamine, Glycerin, Lactic Acid, PEG-120 Methyl Glucose Dioleate, Coco Diisopropanolamide, Fragrance, Trisodium Dicarboxymethyl Alaninate, D&C Green No. 8, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, FD&C Blue No. 1

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

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

Principal Display Panel 3.79 Liters Container Label (Principal Display Panel - 3.79 Liters Container Label)


Advanced Ingredient Data


Raw Label Data

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