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

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings
  • For external use only
  • May irritate eyes
Uses
  • For hand sanitizing to decrease bacteria on the skin.
Purpose

Antiseptic

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.
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.

Description

Benzalkonium chloride 0.13%

Active Ingredient

Benzalkonium chloride 0.13%

Package Labeling:

•  Keep Out Reach of Children

unless under adult supervision


Structured Label Content

Warnings
  • For external use only
  • May irritate eyes
Uses
  • For hand sanitizing to decrease bacteria on the skin.
Purpose

Antiseptic

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.
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.

Active Ingredient

Benzalkonium chloride 0.13%

Package Labeling:

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

unless under adult supervision


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)