First Aid Only Triple Antibiotic Ointment

First Aid Only Triple Antibiotic Ointment
SPL v2
SPL
SPL Set ID e55cbf7e-c955-7f1a-e053-2a95a90a3f28
Route
TOPICAL
Published
Effective Date 2022-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-04

Description

Bacitracin zinc 400 units Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base) Polymyxin - B sulfate 5000 units


Medication Information

Description

Bacitracin zinc 400 units Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base) Polymyxin - B sulfate 5000 units

Section 50565-1

Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51945-4

Carton Image

Section 53413-1

Questions 1.800.835.2263

Section 55105-1
Active ingredient (in each gram) Purpose
Bacitracin Zinc 400 Units First Aid Antibiotic
Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base) First Aid Antibiotic
Polymyxin B Sulfate 5000 Units First Aid Antibiotic
Warnings

For external use only

• Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Directions

Adults and Children Clean the affected area. Apply a small amount of product

(equal to the surface area of a fingertip) 1 to 3 times daily. May be covered with a sterile bandage.

Do Not Use

Do not use • in the eyes •over large areas of the body •if you are allergic to any of the ingredients

•longer than 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns

Other Information

Store at 15°- 30°C (59°- 86°F)

Inactive Ingredient

White Petrolatum

• Active Ingredient

Bacitracin zinc 400 units

Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base)

Polymyxin - B sulfate 5000 units

Stop Use and Ask A Doctor If

•condition persists or gets worse •a rash or allergic reaction occurs

•condition persists for more than 7 days


Structured Label Content

Section 50565-1 (50565-1)

Keep out the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51945-4 (51945-4)

Carton Image

Section 53413-1 (53413-1)

Questions 1.800.835.2263

Section 55105-1 (55105-1)
Active ingredient (in each gram) Purpose
Bacitracin Zinc 400 Units First Aid Antibiotic
Neomycin Sulfate 5mg (Equivalent to 3.5 mg of Neomycin base) First Aid Antibiotic
Polymyxin B Sulfate 5000 Units First Aid Antibiotic
Warnings (WARNINGS)

For external use only

• Uses (• USES)

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Directions (DIRECTIONS)

Adults and Children Clean the affected area. Apply a small amount of product

(equal to the surface area of a fingertip) 1 to 3 times daily. May be covered with a sterile bandage.

Do Not Use (DO NOT USE)

Do not use • in the eyes •over large areas of the body •if you are allergic to any of the ingredients

•longer than 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns

Other Information (OTHER INFORMATION)

Store at 15°- 30°C (59°- 86°F)

Inactive Ingredient (INACTIVE INGREDIENT)

White Petrolatum

• Active Ingredient (• ACTIVE INGREDIENT)

Bacitracin zinc 400 units

Neomycin sulfate 5 mg (equivalent to 3.5 mg. of neomycin base)

Polymyxin - B sulfate 5000 units

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

•condition persists or gets worse •a rash or allergic reaction occurs

•condition persists for more than 7 days


Advanced Ingredient Data


Raw Label Data

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