FDA Label for Pomada De La Campana Triple Antibiotic Pain Relief

View Indications, Usage & Precautions

Pomada De La Campana Triple Antibiotic Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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