b7b0e822-ecc7-401e-e053-2a95a90ad7f4

SPL v3
SPL
SPL Set ID b7b0e822-ecc7-401e-e053-2a95a90ad7f4
Route
topical
Published
Effective Date 2020-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
water tetrasodium glutamate diacetate dehydroacetic acid phenoxyethanol c12-15 pareth-12 benzoic acid glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-03
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13% w/w

Medication Information

Warnings

For external use only

Uses

For handwashing to decrease bacteria on the skin

Purpose

Antibacterial

Directions
  • Storage: Store at room temperature.
  • Dispensing: Peel back label slowly. Pull out wipe and reseal label. Close label to retain moisture.
  • Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
  • Disposal: Dispose of used wipes in trash receptable after use. Do not flush.

Inactive Ingredients

Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol,

Description

Benzalkonium Chloride 0.13% w/w

Section 50566-9

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Packaging

Do Not Use
  • in the eyes.
  • if you are allergic to any of ingredients.

Package Label

Kills 99.9% of Germs that may cause illness.

6.3 IN x 7.1 IN

(16 cm x 18 cm)

Questions? +1 (862) 257-3339

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

Distributed by: G&Y Products, Inc.

25 Shady St, Paterson, NJ 07524

[email protected]

Country of origin: Turkey

Active Ingredients

Benzalkonium Chloride 0.13% w/w

When Using This Product

if eye contact occurs, rinse eyes thoroughly with water

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only

Uses

For handwashing to decrease bacteria on the skin

Purpose

Antibacterial

Directions
  • Storage: Store at room temperature.
  • Dispensing: Peel back label slowly. Pull out wipe and reseal label. Close label to retain moisture.
  • Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
  • Disposal: Dispose of used wipes in trash receptable after use. Do not flush.

Inactive Ingredients

Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol,

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Packaging

Do Not Use (Do not use)
  • in the eyes.
  • if you are allergic to any of ingredients.

Package Label (Package label)

Kills 99.9% of Germs that may cause illness.

6.3 IN x 7.1 IN

(16 cm x 18 cm)

Questions? +1 (862) 257-3339

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

Distributed by: G&Y Products, Inc.

25 Shady St, Paterson, NJ 07524

[email protected]

Country of origin: Turkey

Active Ingredients

Benzalkonium Chloride 0.13% w/w

When Using This Product (When using this product)

if eye contact occurs, rinse eyes thoroughly with water

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:04.206901 · Updated: 2026-03-14T23:00:23.363901