Family Wellness Antiseptic And Pain Relief Ointment
FDA Label NDC 69571-007

Full FDA labeling including 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 Antiseptic And Pain Relief (NDC 69571-007). 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, inactive ingredient, 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)

Bacitricin zinc 500 units

Neomycin  3.5 mg

Polymyxin B  10,000 units

Pramoxine hydrochorlide 10 mg

Otc - Purpose

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Indications & Usage

Uses

helps prevent infection in and reduces paid due to

•minor cuts  •scrapes  •burns

Warnings

Warnings  For external use only

Allergy alert

•do not use if allergic to any of the ingredients

Do not use

•in or near eyes

•on large areas of the body

Ask a doctor before use if you have

•deep or puncture wounds

•animal bites  •serious burns

When using this product

•do not use longer than 1 week

Stop use and ask a doctor if

•condtions last or gets worse

•symptoms last for more than 7 days or clear up and

come back within a few days

•if rash or other allergic reaction occurs

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.

Dosage & Administration

Directions

•adults and children 2 years of age and older:

   •clean affected area

   •apply a small amount (equal to surface area of tip of 

   finger) on area 1 to 3 times dailt

   •may be covered by a sterile bandage

•children under 2 years of age:

   •ask a doctor

Storage And Handling

Other information

•store at room temperature 68° - 77° (20° - 25° C)

Inactive Ingredient

Inactive ingredients mineral oil, white petrolatum

Otc - Questions

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

Package Label.Principal Display Panel

Image Description (Front Anti)

Image Description (Front Anti)

* Please review the disclaimer below.