Pomada De La Campana Triple Antibiotic Pain Relief
FDA Label NDC 50066-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc. for the product Pomada De La Campana Triple Antibiotic Pain Relief (NDC 50066-013). 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, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients                                                                                                                 Purpose

Bacitracin 500 units per gm-------------------------------------------------------------------------First Aid Antibiotic

Neomycin 3.5 mg per gm---------------------------------------------------------------------------First Aid Antibiotic

Polymyxin B 10,000 units per gm------------------------------------------------------------------First Aid Antibiotic

Pramoxine Hydrochoride 10mg---------------------------------------------------------------------First Aid Antibiotic

Otc - Purpose

Uses

First aid to help prevent infection in and temporarily relieve pain due to minor:

Cuts, Scrapes, Burns

Warnings

For external use only

Allergey Alert: Do not use if allergic to any of the ingredients

Otc - Do Not Use

Do not use

in or near the eyes or nose

on large areas of the body

Otc - Ask Doctor

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Otc - When Using

do not use longer than 1 week

Otc - Stop Use

Stop use and ask a doctor if

condition lasts or gets worse

symptoms last more than 7 days or clear up and occur again within a few days

a 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 immediately.

Indications & Usage

Directions

Adults and children 2 years and older:

clean affected area

apply a small 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 2 years and under: ask a doctor

Storage And Handling

Other information

Store at controlled room temperature at 68°-77° (20°-25°)

Inactive Ingredient

Inactive Ingredient

Liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Dosage & Administration

Distributed by:

Genomma lab USA Inc.,

Houston, TX, 77027

Made in Korea

Package Label.Principal Display Panel

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