Topcare Antibiotic Cream
FDA Label NDC 36800-976

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Antibiotic (NDC 36800-976). 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?

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COMPARE TO NEOSPORIN® + PAIN RELIEF ACTIVE INGREDIENTS

First Aid Antibiotic & Pain Relieving Cream

Helps Prevent Infection in Minor Cuts, Scrapes & Burns

Maximum Strength

MAXIMUM STRENGTH

OUR PHARMACISTS RECOMMEND

Antibiotic Cream + Pain Relief

NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl

First Aid Antibiotic / Pain Relieving Cream

NET WT 0.5 OZ (14 g)

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