globe antiseptic spray

globe antiseptic spray
SPL v1
SPL
SPL Set ID 13f1c70f-3b44-8eef-e063-6294a90af634
Route
topical
Published
Effective Date 2024-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 g)
Inactive Ingredients
water alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-18

Purpose

First Aid Antiseptic

Description

Benzalkonium chloride .13%


Medication Information

Warnings

For External Use Only

Flammable. Keep away from fire or flame.

Indications and Usage

First Aid to help prevent infection in minor cuts, scrapes, and burns.

Purpose

First Aid Antiseptic

Directions
  • Clean affected area and spray 1 to 3 times daily
  • May be covered wiht a sterile bandage
  • Not to be used on children under 12 years of age
Other Information
  • Store at controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

Purified water, alcohol

Description

Benzalkonium chloride .13%

Packaging

Do Not Use
  • Near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • for more than one week unless directed by a doctor
Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4069-FBA

Made in China

Active Ingredient

Benzalkonium chloride .13%

Questions Or Comments

Call 1-888-296-9067

Stop Use and Ask A Doctor
  • If the condition persists or gets worse.
Keep Out of the Reach of Children

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


Structured Label Content

Warnings

For External Use Only

Flammable. Keep away from fire or flame.

Indications and Usage (34067-9)

First Aid to help prevent infection in minor cuts, scrapes, and burns.

Purpose

First Aid Antiseptic

Directions
  • Clean affected area and spray 1 to 3 times daily
  • May be covered wiht a sterile bandage
  • Not to be used on children under 12 years of age
Other Information (Other information)
  • Store at controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredients

Purified water, alcohol

Packaging

Do Not Use
  • Near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • for more than one week unless directed by a doctor
Distributed By:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4069-FBA

Made in China

Active Ingredient

Benzalkonium chloride .13%

Questions Or Comments (Questions or Comments)

Call 1-888-296-9067

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • If the condition persists or gets worse.
Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

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