Health-e-wipes Alcohol-free Antiseptic Wipes

Health-e-wipes Alcohol-free Antiseptic Wipes
SPL v7
SPL
SPL Set ID c67ec691-d82c-4762-a925-fb338755b7df
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Diazolidinyl Urea Glycerin Lauryl Betaine Methylparaben Ethylparaben Propylparaben Butylparaben Isobutylparaben Phenoxyethanol Polyoxyl 40 Hydrogenated Castor Oil Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-04-14 Until 2028-01-31

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.
Warnings
  • For external use only
  • May irritate eyes
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 to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.
Active Ingredient

Benzalkonium chloride 0.13%

Package Labeling:

Inactive Ingredients

Aloe barbadensis extract, diazolidinyl urea, fragrance, glycerin, lauryl betain, methylparaben/ethylparaben/propylparaben/butylparaben /isobutylparaben/phenoxyethanol, PEG-40 hydrogenated castor oil, propylene glycol, water.

•  Keep Out Reach of Children

unless under adult supervision


Structured Label Content

Uses
  • For hand sanitizing to decrease bacteria on the skin.
Purpose

Antiseptic

Warnings
  • For external use only
  • May irritate eyes
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 to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.
Active Ingredient

Benzalkonium chloride 0.13%

Package Labeling:

Inactive Ingredients

Aloe barbadensis extract, diazolidinyl urea, fragrance, glycerin, lauryl betain, methylparaben/ethylparaben/propylparaben/butylparaben /isobutylparaben/phenoxyethanol, PEG-40 hydrogenated castor oil, propylene glycol, water.

•  Keep Out Reach of Children (•  Keep out reach of children)

unless under adult supervision


Advanced Ingredient Data


Raw Label Data

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