Other
Drug Facts
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD,
MEMPHIS, TN 38118
Triple Antibiotic Ointment
FDA Label NDC 55315-192
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fred's, Inc. for the product Triple Antibiotic (NDC 55315-192). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each gram) | Purpose |
|---|---|
| Bacitracin zinc USP 500 units | First aid antibiotic |
| Neomycin sulfate USP 3.5 mg | First aid antibiotic |
| Polymyxin B sulfate USP 10,000 units | First aid antibiotic |
| Pramoxine HCl USP 10 mg | External analgesic |
Uses
first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
- cuts
- scrapes
- burns
Warnings
For external use only.
Do Not Use
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
Ask A Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
Stop Use And Ask A Doctor If
- you need to use longer than 1 week
- condition persists or gets worse
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- rash or other allergic reaction develops
Otc - 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.
Directions
- adults and children 2 years of age and older:
- clean the affected area
- apply a small amount of this product (an amount equal to the surface 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 of age: ask a doctor
Other Information
- store at 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredient
white petrolatum
Questions?
Call 1-866-923-4914
Principal Display Panel - 14.2 G Tube Carton
TRIPLE ANTIBIOTIC
OINTMENT
+ PAIN RELIEF
MAXIMUM STRENGTH
Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B
Sulfate USP • Pramoxine Hydrochloride USP
FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT
Helps Prevent Infection in Minor Cuts, Scrapes,
and Burns Plus Maximum Strength Pain Relief.
NET WT 0.5 oz (14.2 g)
Principal Display Panel (14.2 g Tube Carton)
* Please review the disclaimer below.
