h e buddy antibiotic maximum strength plus pain relief

Dosage form: cream
Ingredients: NEOMYCIN 3.5mg in 1g, POLYMYXIN B 10000[USP'U] in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: H E B
NDC Code: 37808-162

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.

HEB Antibiotic Cream Drug Facts

Active ingredient (in each gram)

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine HCl 10 mg

Purpose

First aid antibiotic

External analgesic

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort 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
  • serious burns
  • deep or puncture wounds
  • animal bites

Stop use and ask a doctor if
  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • 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. (1-800-222-1222)

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: ask a doctor

Other information
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS OF NEOSPORIN®

Maximum Strength

ANTIBIOTIC CREAM

+ Pain Relief

FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM

Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCl

Antibiotic Cream Carton Image 1

Antibiotic Cream Carton Image 2

H E BUDDY ANTIBIOTIC  MAXIMUM STRENGTH PLUS PAIN RELIEF
neomycin, polymyxin b, pramoxine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-162
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B (POLYMYXIN B) POLYMYXIN B10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN 
MINERAL OIL 
POLOXAMER 188 
PROPYLENE GLYCOL 
WATER 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:37808-162-581 TUBE (TUBE) in 1 CARTON
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/28/2011
Labeler - H E B (007924756)

Revised: 09/2011
 
H E B

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)