SPL v1
SPL
SPL Set ID cb2958d3-b6ee-4df1-850e-b7fcbe719bcb
Route
TOPICAL
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Aloe Vera Leaf Water Phenoxyethanol Polysorbate 20 Propylene Glycol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-15

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Use

For hand sanitizing to decrease bacteria on the skin.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Directions
  • Tear V notch located on top of the plastic bag.
  • Pull out the first wipe approximately 6 to 8 inches from the center of the roll.
  • Place entire bag inside of center pull dispenser.
  • Thread the wipe through the opening on the dispenser.
  • Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.
  • Apply topically to the skin
  • Recommended for repeated use.
  • Dries in seconds.
  • For children under 6, use only under adult supervision. Not recommended for infants
  • Discard wipe in trash receptable after use. Do not flush
Product Label

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Water(Aqua), Fragrance(Parfum), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate


Structured Label Content

Use

For hand sanitizing to decrease bacteria on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Warnings

For external use only.

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Directions
  • Tear V notch located on top of the plastic bag.
  • Pull out the first wipe approximately 6 to 8 inches from the center of the roll.
  • Place entire bag inside of center pull dispenser.
  • Thread the wipe through the opening on the dispenser.
  • Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.
  • Apply topically to the skin
  • Recommended for repeated use.
  • Dries in seconds.
  • For children under 6, use only under adult supervision. Not recommended for infants
  • Discard wipe in trash receptable after use. Do not flush
Product Label

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Water(Aqua), Fragrance(Parfum), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)