Triple Antibiotic Ointment

Triple Antibiotic Ointment
SPL v1
SPL
SPL Set ID 0e1b23f3-fa1e-f42b-e063-6394a90a3bec
Route
TOPICAL
Published
Effective Date 2024-01-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Neomycin (3.5 mg) Polymyxin B (5000 U) Bacitracin (400 U)
Inactive Ingredients
Cetostearyl Alcohol Glycerin Water Polyoxyl 20 Cetostearyl Ether Isopropyl Myristate Aloe Vera Leaf Phenoxyethanol Edetate Disodium Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-04

Description

Bacitracin Zinc 400U/g Neomycin Sulfate (3.5mg Neomycin) Polymyxin B Sulfate 5000U/g

Purpose

Antibiotics


Medication Information

Purpose

Antibiotics

Description

Bacitracin Zinc 400U/g Neomycin Sulfate (3.5mg Neomycin) Polymyxin B Sulfate 5000U/g

Uses

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

Section 44425-7

Other information

protect from Excessive Heat (40 oC/ 104 oF.)

Section 50565-1

Keep out of reach of children. If ingested, contact Poison Control Center right away.

Section 50566-9

Stop use and ask doctor if

  • condition worsens or if symptoms persist for more than 7 days
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50569-3

Ask a doctor before use if you are using any other hydrocortisone product

Section 51945-4

Warnings

For external use only.

Do not use.

  • in or near the eyes
  • for diaper rash; ask a doctor
Directions
  • apply to affected area not more than 3 to 4 times daily
  • children under 2 years do not use; ask a doctor
Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin, Glycerin, Ceteareth-20, Isopropyl Myristate, Disodium EDTA, Phenoxyethanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

Active Ingredients (in Each Gram)

Bacitracin Zinc 400U/g

Neomycin Sulfate (3.5mg Neomycin)

Polymyxin B Sulfate 5000U/g


Structured Label Content

Uses

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

Section 44425-7 (44425-7)

Other information

protect from Excessive Heat (40 oC/ 104 oF.)

Section 50565-1 (50565-1)

Keep out of reach of children. If ingested, contact Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • condition worsens or if symptoms persist for more than 7 days
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50569-3 (50569-3)

Ask a doctor before use if you are using any other hydrocortisone product

Section 51945-4 (51945-4)

Purpose

Antibiotics

Warnings

For external use only.

Do not use.

  • in or near the eyes
  • for diaper rash; ask a doctor
Directions
  • apply to affected area not more than 3 to 4 times daily
  • children under 2 years do not use; ask a doctor
Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin, Glycerin, Ceteareth-20, Isopropyl Myristate, Disodium EDTA, Phenoxyethanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Bacitracin Zinc 400U/g

Neomycin Sulfate (3.5mg Neomycin)

Polymyxin B Sulfate 5000U/g


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)