H E Buddy Antibiotic Maximum Strength Plus Pain Relief: Package Insert and Label Information

H E BUDDY ANTIBIOTIC MAXIMUM STRENGTH PLUS PAIN RELIEF- neomycin, polymyxin b and pramoxine hydrochloride cream
H E B

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.

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
(click image for full-size original)

Antibiotic Cream Carton Image 1

Antibiotic Cream Carton Image 2
(click image for full-size original)

Antibiotic Cream Carton Image 2

H E BUDDY ANTIBIOTIC MAXIMUM STRENGTH PLUS PAIN RELIEF
neomycin, polymyxin b, pramoxine hcl cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-162
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B (POLYMYXIN B) POLYMYXIN B 10000 [USP'U] in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
MINERAL OIL
POLOXAMER 188
PROPYLENE GLYCOL
WATER
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-162-58 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 14 g in 1 TUBE This package is contained within the CARTON (37808-162-58)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 01/28/2011
Labeler — H E B (007924756)

Revised: 09/2011 H E B

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