Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID efbb369f-faf3-b98f-e053-2995a90a22cd
Route
TOPICAL
Published
Effective Date 2021-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-12-13

Description

Benzalkonium chloride 0.13%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Benzalkonium chloride 0.13%

Uses
  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use
Warnings

For external use only

Directions
  • take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe
  • rub hands together briskly to dry without wiping
  • dispose of wipe
  • do not flush
Active Ingredient

Benzalkonium chloride 0.13%

Other Information

Store between 15°-30°C (59°F - 86°F).

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Purified Water, Aloe Barbadensis Leaf Extract, Citric Acid, Fragrance, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Vitamin E

Principal Display Panel

73030-025-01

ANTI-BACTERIAL WIPES

SMELLS AMAZING • SOFTENS HANDS

10 BIG WIPES

KILLS 99.9% OF GERMS

DO NOT FLUSH

When Using This Product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor

If irritation or redness develops, or if 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

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

Antimicrobial

Warnings

For external use only

Directions
  • take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe
  • rub hands together briskly to dry without wiping
  • dispose of wipe
  • do not flush
Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

Other Information (Other information)

Store between 15°-30°C (59°F - 86°F).

Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

Purified Water, Aloe Barbadensis Leaf Extract, Citric Acid, Fragrance, Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Sodium Benzoate, Vitamin E

Principal Display Panel

73030-025-01

ANTI-BACTERIAL WIPES

SMELLS AMAZING • SOFTENS HANDS

10 BIG WIPES

KILLS 99.9% OF GERMS

DO NOT FLUSH

When Using This Product (When using this product)

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation or redness develops, or if 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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