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  5. Label Information: Antibiotic Plus Pain Relief

FDA Label for Antibiotic Plus Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH GRAM)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Gram)



Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

Pramoxine HCl 10 mg


Purpose



First aid antibiotic

External analgesic


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.


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

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



  • •adults and children 2 years of age or 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 20o-25oC (68o-77oF)

Inactive Ingredients



emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum


Questions Or Comments?



1-800-632-6900


Package/Label Principal Display Panel



COMPARE TO active ingredients of NEOSPORIN® + PAIN RELIEF CREAM

See back panel

Maximum Strength

Antibiotic Cream + Pain Relief

First Aid Antibiotic/Pain Relieving Cream

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

NET WT .5 OZ (14g)


* Please review the disclaimer below.