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

Purpose

Antiseptic

Description

Chloroxylenol 0.5%


Medication Information

Warnings

For external use only

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

Antiseptic

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
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

Description

Chloroxylenol 0.5%

Do Not Use

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

Active Ingredient

Chloroxylenol 0.5%

Package Labeling:

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

Warnings

For external use only

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

Antiseptic

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
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

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:

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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