Other
Drug Facts
Shopko Ointment
FDA Label NDC 37012-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shopko Stores Operating Co., Llc for the product Shopko (NDC 37012-027). 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 (each gram contains) | Purpose |
|---|---|
| Bacitracin zinc 500 units | First aid antibiotic |
| Neomycin sulfate 3.5 mg | First aid antibiotic |
| Polymyxin B sulfate 10,000 units | First aid antibiotic |
| Pramoxine hydrochloride 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
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
Ask A Doctor Before Use If You Have
- deep or puncture wounds
- animal bites
- serious burns
Stop Use And Ask A Doctor If
- condition persists or gets worse
- you need to use longer than 1 week
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- a 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 and dry thoroughly
- 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
- To open: unscrew cap, pull tab to remove foil seal
- 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 - 28.4 G Tube Carton
SHOPKO®
NDC 37012-027-02
Maximum Strength
Triple Antibiotic Ointment+Pain Relief
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride
First Aid Antibiotic / Pain Relieving Ointment
NET WT 1 OZ (28.4 g)
Principal Display Panel (28.4 g Tube Carton)
* Please review the disclaimer below.
