Simple Hygiene Antibacterial Foam Hand Soap

Simple Hygiene Antibacterial Foam Hand Soap
SPL v2
SPL
SPL Set ID 184a8dd5-1586-4a24-9ed8-32a8a45bc9b7
Route
TOPICAL
Published
Effective Date 2022-02-25
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 Yellow No. 6 D&c Red No. 33 Isopropyl Alcohol Lauramine Oxide Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01

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%

Inactive Ingerdients

Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Yellow No. 6, D&C Red No. 33, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Oletin Sulfonate, Water

Stop Use and Ask A Doctor If
  • irritatation and redness develop
  • condition persists for more than 72 hours
Package Labeling:60933 106 01

Package Labeling:60933 106 02

Package Labeling:60933 106 03

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%

Inactive Ingerdients

Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Yellow No. 6, D&C Red No. 33, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Oletin Sulfonate, Water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritatation and redness develop
  • condition persists for more than 72 hours
Package Labeling:60933 106 01 (Package Labeling:60933-106-01)

Package Labeling:60933 106 02 (Package Labeling:60933-106-02)

Package Labeling:60933 106 03 (Package Labeling:60933-106-03)

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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