Simple Hygiene Antibacterial Foam Hand Soap

Simple Hygiene Antibacterial Foam Hand Soap
SPL v5
SPL
SPL Set ID a094c58d-5304-4132-8614-b9c0d5942e01
Route
TOPICAL
Published
Effective Date 2018-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloroxylenol (5 mg)
Inactive Ingredients
Aloe Vera Leaf Citric Acid Monohydrate Edetate Disodium Anhydrous Fd&c Blue No. 1 Fd&c Yellow No. 5 Lauramine Oxide Water Isopropyl Alcohol Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-01

Description

Chloroxylenol 0.5%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Chloroxylenol 0.5%

Uses
  • For hand washing to decrease the bacteria on skin.
  • Recommended for repeated use
Warnings

For external use only

Directions
  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together to produce a thick lather
  • Rinse and repeat
Do Not Use

in the eyes. In case of contact, flush eyes with water.

Active Ingredient

Chloroxylenol 0.5%

Package Labeling:

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Olefin Sulfonate, Water

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours
Keep Out of Reach of Children. 

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


Structured Label Content

Uses
  • For hand washing to decrease the bacteria on skin.
  • Recommended for repeated use
Purpose

Antiseptic

Warnings

For external use only

Directions (DIRECTIONS)
  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together to produce a thick lather
  • Rinse and repeat
Do Not Use (Do not use)

in the eyes. In case of contact, flush eyes with water.

Active Ingredient (Active ingredient)

Chloroxylenol 0.5%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Olefin Sulfonate, Water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • condition persists for more than 72 hours
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.


Advanced Ingredient Data


Raw Label Data

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