Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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LUCKY SUPERSOFT FIRST AID- bacitracin neomycin polymyxin b ointment 
Delta Brands, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Use

first aid to help prevent infection in minor:  ■ cuts ■ scrapes ■ burns

Warnings

For external use only

Do not use

■ if you are allergic to any of the ingredients ■ in the eyes ■ over large areas of the body

Ask a doctor before use if you have 

■ deep or puncture wounds ■ serious burns ■ animal bites 

Stop use and consult a doctor if

■ you need to use longer than 1 week ■ condition persists or gets worse ■ 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

■ 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

Other information

■ store at room temperature 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Package Label

image description

LUCKY SUPERSOFT  FIRST AID
bacitracin neomycin polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 20276-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER (UNII: 512OYT1CRR)  
COTTONSEED OIL (UNII: H3E878020N)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SODIUM PYRUVATE (UNII: POD38AIF08)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 20276-103-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/31/2015
Labeler - Delta Brands, Inc (102672008)

Revised: 2/2015
 
Delta Brands, Inc


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