ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Antibiotic Plus Pain Relief by

Drug Labeling and Warnings

Antibiotic Plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Phoenix Global Supply Group, Inc., SGS Life Science Services, Axellia Pharmaceuticals ApS, Pharmacia and UpJohn Company, Syn-Tech Chem. & Pharm. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCl 10 mg	External analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

• cuts
• scrapes
• burns

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
• condition persists for more than 7 days
• condition clears up and occurs again within a few days
• a rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older:
  • clean the affected area
  • 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
• children under 2 years of age: consult a doctor

Other information

• To open: unscrew cap, pull tab to remove foil seal.
• store at 20°-25°C (68°-77°F)
• See carton or tube crimp for lot number and expiration date.

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

Questions?

Call 1-877-745-6888

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Distributed by:
Phoenix Global Supply Group, Inc.
White Plains, NY 10604

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Antibiotic
Cream + Pain Relief
Neomycin Sulfate Polymyxin B Sulfate Pramoxine HCl

First Aid Antibiotic / Pain Relieving Cream

Maximum Strength

NET WT 1 oz (28.4 g)

INGREDIENTS AND APPEARANCE

ANTIBIOTIC PLUS PAIN RELIEF 
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52426-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin Sulfate	3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B Sulfate	10000 [iU]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
petrolatum (UNII: 4T6H12BN9U)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52426-220-05	1 in 1 CARTON
1		14.2 g in 1 TUBE
2	NDC: 52426-220-06	1 in 1 CARTON
2		28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	09/23/2010

Labeler - Phoenix Global Supply Group, Inc. (843189908)

Establishment
Name	Address	ID/FEI	Business Operations
SGS Life Science Services		093840643	ANALYSIS

Establishment
Name	Address	ID/FEI	Business Operations
Axellia Pharmaceuticals ApS		305814345	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacia and UpJohn Company		829076566	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Syn-Tech Chem. & Pharm. Co., Ltd.		656002532	API MANUFACTURE