Globe First Aid Antibiotic Plus Burn Relief

Globe First Aid Antibiotic Plus Burn Relief
SPL v2
SPL
SPL Set ID 048871e2-c917-292d-e063-6394a90af130
Route
TOPICAL
Published
Effective Date 2023-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg) Polymyxin B (10000 [USP'U]) Bacitracin (500 [USP'U]) Neomycin (3.5 mg)
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-04

Description

Pramoxine HCI

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Pramoxine HCI

Uses

First Aid to help prevent infection and for the temporary relief of pain or discomfort in minor cuts, scrapes and burns.

Section 51945-4

Section 55106-9

Neomycin Sulfate

Warnings

For external Use Only

Questions

Call 1-888-296-9067

Directions

Adults and children 2 years of age and older:

  • Clean the affected area and dry thoroughly.
  • Apply a small amount of this product , an mount equal to the surgace area of the tip of a finger) on the area 1 to 3 times daily
  • May be covered with a sterile bandage

Children under 2 years old: ask a doctor

Do Not Use

Do Not use

  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
Purpose Section

External Analgesic

Active Ingredient

Pramoxine HCI

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Storage Information

  • Store at 20° to 25°C (68° to 77°F).
  • See carton or tube crimp for lot number and expiration date
Inactive Ingredients

White Petrolatum

Stop Use and Ask A Doctor If
  • Condition persists or gets worse
  • You need to use longer than 1 week
  • A rash or other allergic reaction develops
  • symptoms persist for more than 1 week or clear up and occur again within a few days
Keep Out of Reach of Children

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

Ask Doctor Before Use If You Have
  • Deep or puncture wounds
  • Animal Bites
  • Serious Burns

Structured Label Content

Uses

First Aid to help prevent infection and for the temporary relief of pain or discomfort in minor cuts, scrapes and burns.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Neomycin Sulfate

Purpose

First Aid Antibiotic

Warnings

For external Use Only

Questions

Call 1-888-296-9067

Directions

Adults and children 2 years of age and older:

  • Clean the affected area and dry thoroughly.
  • Apply a small amount of this product , an mount equal to the surgace area of the tip of a finger) on the area 1 to 3 times daily
  • May be covered with a sterile bandage

Children under 2 years old: ask a doctor

Do Not Use

Do Not use

  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
Purpose Section

External Analgesic

Active Ingredient

Pramoxine HCI

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Storage Information

  • Store at 20° to 25°C (68° to 77°F).
  • See carton or tube crimp for lot number and expiration date
Inactive Ingredients

White Petrolatum

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)
  • Condition persists or gets worse
  • You need to use longer than 1 week
  • A rash or other allergic reaction develops
  • symptoms persist for more than 1 week or clear up and occur again within a few days
Keep Out of Reach of Children (Keep out of reach of children)

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

Ask Doctor Before Use If You Have (Ask Doctor before use if you have)
  • Deep or puncture wounds
  • Animal Bites
  • Serious Burns

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)