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, Xellia 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 (in each gram)	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 bacterial contamination and prevent infection and for the temporary relief of pain and itching 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 for more than 7 days
• condition persists or gets worse
• 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 one or more pumps 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

• store at 20°- 25°C (68°-77°F)
• See card or pump for lot number and expiration date
• one pump contains .05±.01 grams

Inactive ingredients

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

Questions?

Call 1-877-745-6888 or visit www.myxcin-ab.com

PRINCIPAL DISPLAY PANEL - 10 g Blister Pack

New!

MAXIMUM STRENGTH

MYXCIN™-AB

Neomycin Sulfate Polymyxin B Sulfate Pramoxine HCl

FIRST AID ANTIBIOTIC CREAM
Plus PAIN & ITCH RELIEF

Neat
Fingertip
Dose Pump!

Helps Heal, Protect
& Relieve Itching in:

• Cuts
• Scrapes
• Burns

ADVANCED
WOUND
MANAGEMENT ™

OVER
200
PUMPS

0.35 oz (10 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: 52426-220-04	1 in 1 BLISTER PACK
1		10 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	07/01/2011

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
Xellia Pharmaceuticals ApS		305814345	MANUFACTURE

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

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