Family Wellness Original Ointment
FDA Label NDC 69396-041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc. for the product Family Wellness Original (NDC 69396-041). 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 (each gram contains), purpose, otc - keep out of reach of children, indications & usage, warnings, directions, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (Each Gram Contains)

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

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.

Indications & Usage

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings

Warnings For external use only.

Do not use ● in the eyes ● over large areas of the body

● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds ● animal bites ● serious burns.

Stop use and ask a doctor if condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops

Directions

● clean the affected area and dry thoroughly.

● 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.

Inactive Ingredient

Inactive ingredient Cetyl Alcohol, Light Mineral Oil, White Petrolatum, Squalane, Stearic Acid, Vitamin E

Other Information

● To open: unscrew cap, pull tab to remove foil seal

● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube for lot number and expiration date.

Otc - Questions

Questions? Call 1-888-296-9067 Weekdays: 9AM - 4PM EST

Other

DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

500 Volvo Parkway, Chesapeake, VA. 23320

NOT 100% SATISFIED?

Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin®

* Please review the disclaimer below.