Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 8f2c1911-6643-4c8f-9ea9-97a16910c6c9
Route
TOPICAL
Published
Effective Date 2021-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Phenoxyethanol Decyl Glucoside Potassium Sorbate Sodium Benzoate Edetate Disodium Anhydrous Citric Acid Monohydrate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-26
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

​Do not use if you are allergic to any of these ingredients

Directions
  • adults and childrens 2 years and over: apply to hands, allow to dry without wiping
  • children under 2 years: ask a doctor before use   
Active Ingredient

Benzalkonium chloride.........0.13%

Other Information
  • Store at room temperature
  • keep closed tightly
  • may discolor certain fabrics or surfaces
Inactive Ingredients

Purified Water, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Fragrance.

Principal Display Panel

NDC: 63940-036-36

Compare to Purell ®​ Hand Sanitizing Wipes

36 hand wipes

CORE VALUES TM​antibacterial 

Hand Wipes

KILLS 99.9% of germs

Clean Scent

Perfect for Travel

36 - Wet Hand Wipes

5.7 in. x 7.5 in. (14.5cm x 19.1cm)

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 (1-800-222-1222)

Structured Label Content

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

Antimicrobial

Warnings

For external use only

​Do not use if you are allergic to any of these ingredients

Directions
  • adults and childrens 2 years and over: apply to hands, allow to dry without wiping
  • children under 2 years: ask a doctor before use   
Active Ingredient (Active ingredient)

Benzalkonium chloride.........0.13%

Other Information (Other information)
  • Store at room temperature
  • keep closed tightly
  • may discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Purified Water, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Fragrance.

Principal Display Panel

NDC: 63940-036-36

Compare to Purell ®​ Hand Sanitizing Wipes

36 hand wipes

CORE VALUES TM​antibacterial 

Hand Wipes

KILLS 99.9% of germs

Clean Scent

Perfect for Travel

36 - Wet Hand Wipes

5.7 in. x 7.5 in. (14.5cm x 19.1cm)

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 (1-800-222-1222)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:51.229197 · Updated: 2026-03-14T23:05:56.026643