b7bd6f74-b129-3654-e053-2a95a90aa89a

SPL v3
SPL
SPL Set ID b7bd6f74-b129-3654-e053-2a95a90aa89a
Route
topical
Published
Effective Date 2020-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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, Purified Water, Tetrasodium Glutamate Diacetate.

Description

Benzalkonium Chloride 0.13% w/w

Packaging

Do Not Use
  • in the eyes.
  • if you are allergic to any of the 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 Ingredient(s)

Benzalkonium Chloride 0.13% w/w

When Using This Product

if eye contact occurs, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor

if irritation and redness develop and persist 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

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, Purified Water, Tetrasodium Glutamate Diacetate.

Packaging

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

Benzalkonium Chloride 0.13% w/w

When Using This Product (When using this product)

if eye contact occurs, rinse eyes thoroughly with water.

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

if irritation and redness develop and persist 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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