Antibiotic Plus Pain Relief Cream
FDA Label NDC 30142-790

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Antibiotic Plus Pain Relief (NDC 30142-790). 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 active ingredients (in each gram), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, 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

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)

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