DR BELLS POMADE- triple antibiotic plus pain relief ointment

DR BELLS POMADE by

Drug Labeling and Warnings

DR BELLS POMADE by is a Otc medication manufactured, distributed, or labeled by Genomma lab USA Inc., Faria LLC dba Sheffield Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Uses

First aid helps prevent infection in and temporarily relieves pain due to:

• cuts
• scrapes
• burns

Warnings

For external use only

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

Do not use

• in or near the eyes or nose
• on large areas of the body

Consult 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 consult a doctor if

• condition persists or gets worse
• symptoms last for more than 7 days or clear up and come back within a few days
• a rash or other allergic reaction develops

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years and older.

• clean the affected area
• apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
• may be covered with a sterile bandage

Children 2 years and under ask a doctor

Other information

• Store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive ingredient

White Petrolatum

Questions? 1-877-99 GENOM ( 43666)

Principal Display Panel – Carton Label

POMADA DE LA CAMPANA

Originial Ointment 

First Aid Antibiotic + Pain Relief Ointment

NET WT. 0.5 oz ( 14g)

Principal Display Panel – Tube Label

POMADA DE LA CAMPANA

Originial Ointment

First Aid Antibiotic + Pain Relief Ointment

Triple Antibiotic + Pain Relief

• Bacitracin Zinc
• Neomycin Sulfate 
• Polymixin B Sulfate
• Pramoxine HCL

NET WT. 0.5 oz ( 14g)

 

 

 

 

 

INGREDIENTS AND APPEARANCE

DR BELLS POMADE 
triple antibiotic plus pain relief ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [USP'U]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-161-51	1 in 1 CARTON
1		14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	05/16/2012

Labeler - Genomma lab USA Inc. (832323534)

Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Faria LLC dba Sheffield Pharmaceuticals		151177797	manufacture(50066-161)