Leader Triple Antibiotic and Pain Relief: Package Insert and Label Information

LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride ointment
Cardinal Health

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 ingredients (in each gram)

Bacitracin zinc 500 units

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B sulfate

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

deep or puncture wounds
animal bites
serious burns

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 or 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 ingredient

white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Maximum Strength

Triple Antibiotic Ointment + Pain Relief

Bacitracin Zinc | Neomycin Sulfate | Polymyxin B Sulfate | Pramoxine HCl

COMPARE TO NEOSPORIN® + PAIN RELIEF active ingredients

First Aid Antibiotic Pain Relieving Ointment

Soothes Cuts, Scrapes and Burns

100% Money Back Guarantee

NET WT 1 OZ (28 g)

triple antibiotic ointment plus pain relief image
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LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF
bacitracin, neomycin, polymyxin b, pramoxine hcl ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0390
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 [USP’U] in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (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
PETROLATUM
Product Characteristics
Color YELLOW (Translucent) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70000-0390-1 1 TUBE in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (70000-0390-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 12/13/2018
Labeler — Cardinal Health (097537435)

Revised: 07/2019 Cardinal Health

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