Hy-Vee, Inc. Triple Antibiotic + Pain Relief Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin, neomycin, polymyxin b, pramoxine hcl ointment 
HyVee 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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Hy-Vee, Inc. Triple Antibiotic + Pain Relief Drug Facts

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

COMPARE TO the Active Ingredients of Neosporin® + Pain Relief

Triple Antibiotic + Pain Relief

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

First Aid Antibiotic – Pain Relieving Ointment

Maximum Strength

Soothes Painful Cuts, Scrapes & Burns

Helps Prevent Infection

Helps Skin Heal to Look Healthy

NET WT 1 OZ (28 g)

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin, neomycin, polymyxin b, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-679
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	YELLOW (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-679-64	1 in 1 CARTON	09/27/2015	05/29/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	09/27/2015	05/29/2019

Labeler - HyVee Inc (006925671)

Revised: 7/2019

Document Id: ae9b4793-6ddc-40f5-b880-9a1bdc5a05e9

34390-5

Set id: 69a4b642-b7ec-43cc-aa57-6858da0b3d63

Version: 2

Effective Time: 20190719