SPL v1
SPL
SPL Set ID c68d426c-64be-d2d2-e053-2a95a90a90da
Route
TOPICAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (126 mg)
Inactive Ingredients
Diethylene Glycol Monoethyl Ether Water Trolamine Carbomer Homopolymer Type A (allyl Pentaerythritol Crosslinked) Propylene Glycol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-11-01

Description

Benzalkonium chloride (0.13%)


Medication Information

Indications and Usage
  • Antiseptic preparation to decrease bacteria on skin
Dosage and Administration
  • Use every 4-8 hours as needed
  • Children under age 12 use adult supervision
Description

Benzalkonium chloride (0.13%)

Uses
  • Helps reduce bacteria that can cause skin infections
Warnings

For external use only.

Directions
  • Open gel packets and apply gel to tip of applicator
  • Insert tip with gel into the right nostril, rotating it a few times, then rotate it in the opposite direction.
  • Using a second applicator, apply gel to tip and repeat step #2 in the left nostril
  • Do not blow nose immediately after use.

Do Not Use
  • If you are allegic to any of the ingredients
  • In or near eyes
  • On children under 2 years of age
Questions?

Call 1-844-4MY-NASO (1-844-469-6276) M-F 9am to 5pm PST

Nasoclenz.com

Active Ingredient

Benzalkonium chloride (0.13%)

Other Information

Best if stored at 59-84F (19-29C)

Inactive Ingredients

Carbomer, Diethylene Glycol Monoethyl Ether, Glycerin, Propylene Glycol, Triethanolamine, Water

Principal Display Panel

Stop Use and Ask A Doctor If
  • Irritation, swelling, pain or other allergic reaction develops
  • Infection occurs
Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have
  • Deep or puncture wounds
  • Serious burns

Structured Label Content

Uses
  • Helps reduce bacteria that can cause skin infections
Indications and Usage (34067-9)
  • Antiseptic preparation to decrease bacteria on skin
Dosage and Administration (34068-7)
  • Use every 4-8 hours as needed
  • Children under age 12 use adult supervision
Warnings

For external use only.

Directions
  • Open gel packets and apply gel to tip of applicator
  • Insert tip with gel into the right nostril, rotating it a few times, then rotate it in the opposite direction.
  • Using a second applicator, apply gel to tip and repeat step #2 in the left nostril
  • Do not blow nose immediately after use.

Do Not Use
  • If you are allegic to any of the ingredients
  • In or near eyes
  • On children under 2 years of age
Questions?

Call 1-844-4MY-NASO (1-844-469-6276) M-F 9am to 5pm PST

Nasoclenz.com

Active Ingredient

Benzalkonium chloride (0.13%)

Other Information (Other information)

Best if stored at 59-84F (19-29C)

Inactive Ingredients

Carbomer, Diethylene Glycol Monoethyl Ether, Glycerin, Propylene Glycol, Triethanolamine, Water

Principal Display Panel

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Irritation, swelling, pain or other allergic reaction develops
  • Infection occurs
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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Deep or puncture wounds
  • Serious burns

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)