Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID e3b3ad1c-7650-65d6-e053-2a95a90af219
Route
TOPICAL
Published
Effective Date 2022-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Aloe Vera Leaf Citric Acid Monohydrate Potassium Sorbate Polysorbate 20 Glycerin Phenoxyethanol Sodium Benzoate Decyl Glucoside Ethylhexylglycerin .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-07-13

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses
  • For hand sanitizing to decrease bacteria on the skin.
  • Apply topically to the skin to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.
Warnings
  • For external use only.
  • May irritate eyes.
Directions
  • Tear V notch on top of plastic bag.
  • Pull first wipe from the center of roll up through opening of bag.
  • Thread first wipe through the dispensing nozzle in lid of floor stand or
  • Thread first wipe through dispensing nozzle in top of wll mounted dispenser.
  • Close dispenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.
Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredient

Purified Water, Polysorbate 20, Glycerin, Phenoxyethanol, Sodium Benzoate, Citric Acid, Fragrance, Potassium Sorbate, Decyl Glucoside, Ethylhexylglycerin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

Wipesplus

SANITIZING ALCOHOL FREE WIPES

Kills 99.9% of germs

240CT

1500CT

800CT

400CT

Keep Out of the Reach of Children Unless Under Adult Supervision

Keep out of the reach of children unless under adult supervision


Structured Label Content

Uses
  • For hand sanitizing to decrease bacteria on the skin.
  • Apply topically to the skin to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.
Purpose

Antiseptic

Warnings
  • For external use only.
  • May irritate eyes.
Directions
  • Tear V notch on top of plastic bag.
  • Pull first wipe from the center of roll up through opening of bag.
  • Thread first wipe through the dispensing nozzle in lid of floor stand or
  • Thread first wipe through dispensing nozzle in top of wll mounted dispenser.
  • Close dispenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.
Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredient

Purified Water, Polysorbate 20, Glycerin, Phenoxyethanol, Sodium Benzoate, Citric Acid, Fragrance, Potassium Sorbate, Decyl Glucoside, Ethylhexylglycerin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Principal Display Panel

Wipesplus

SANITIZING ALCOHOL FREE WIPES

Kills 99.9% of germs

240CT

1500CT

800CT

400CT

Keep Out of the Reach of Children Unless Under Adult Supervision (Keep out of the reach of children unless under adult supervision)

Keep out of the reach of children unless under adult supervision


Advanced Ingredient Data


Raw Label Data

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