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Distributed by McKesson
One Post Street
San Francisco, CA 94104
Sunmark Ointment
FDA Label NDC 49348-600
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Sunmark (NDC 49348-600). 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, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, 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) | Purposes |
|---|---|
| Bacitracin 500 units | First aid antibiotic |
| Neomycin 3.5 mg | First aid antibiotic |
| Polymyxin B 10,000 units | First aid antibiotic |
| Pramoxine HCl 10 mg | Topical pain reliever |
Uses
first aid to help prevent infection and for temporary relief of pain or discomfort in minor:
- cuts
- scrapes
- burns
Warnings
For external use only
Otc - Do Not Use
Do not use if you are allergic to any of the ingredients
Otc - Ask Doctor
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Otc - When Using
When using this product
- do not use in the eyes
- do not apply over large areas of the body
Otc - Stop Use
Stop use and ask a doctor if
- you need to use for more 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
- unscrew cap and pull tab to remove foil seal
- 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 controlled room temperature 15°-30°C (59°-86°F)
- see carton or tube crimp for lot number and expiration date
Inactive Ingredient
white petrolatum
Principal Display Panel - 28.4 G Tube Carton
sunmark™
triple antibiotic ointment
plus pain reliever
polymyxin B sulfate • bacitracin zinc
neomycin sulfate • pramoxine hydrochloride
First Aid Antibiotic
MAXIMUM STRENGTH
NET WT 1 OZ (28.4 g)
Principal Display Panel (28.4 g Tube Carton)
* Please review the disclaimer below.
