Family Wellness Ointment
FDA Label NDC 69571-003

10 label sections · Submitted to the FDA by Front Pharmaceutical Plc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Front Pharmaceutical Plc for the product Family Wellness (NDC 69571-003). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Otc - Purpose

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Indications & Usage

  first aid to help prevent infection in minor: Uses

-uses     -scrapes   -burns

Warnings

Warnings

. For external use only

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

  • if you are allergic to any of the ingredients in this product
  • in contact with the eyes or mucous membranes
  • over large areas of the body
    • deep or puncture wounds
    • animal bites
    • serious burns
      • symptoms persist for mroe than 7 days, the condition persists or gets worse
      • symptoms clear up and then occur again within a few days
      • a rash or other allergic reaction occurs

Otc - Keep Out Of Reach Of Children

. If swallowed, get medical help or Keep out of reach of children

contact a Poison Control Center right away.

Dosage & Administration

Directions

Adults and children 2 years of age and older:

Children under 2 years of age: ask a doctor before use.

  • clean the affected area
  • apply a small amount of this product to affected area 1 to 3 times daily
  • May be covered with a sterile bandage.

Storage And Handling

  store at room temperature 68 - 77 F Other information

(20-25 C).

Otc - Questions

  1-800-639-3803  Weekdays 9 AM to 4 PM EST Questions?

Inactive Ingredient

  mineral oil, petrolatum Inactive ingredients

Package Label.Principal Display Panel

Image Description (Anti2 Label)

Image Description (Anti2 Label)

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