CAREONE ORIGINAL STRENGTH TRIPLE ANTIBIOTIC- bacitracin neomycin polymyxin b ointment

Careone Original Strength Triple Antibiotic by

Drug Labeling and Warnings

Careone Original Strength Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Foodhold U.S.A. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram)                                             Purpose

Bacitracin 400 units.............................................................. First aid antibiotic

Neomycin 3.5 mg................................................................. First aid antibiotic

Polymyxin B 5,000 units........................................................ First aid antibiotic

PURPOSE

Uses

First aid to help prevent infection in minor:

• cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• if you are allergic to any of the ingredients
• in or near the eyes
• over large areas of the body

ASK DOCTOR

Ask a doctor berfore use if you have

• deep or puncture wounds
• animal bites
• serious burns

STOP USE

Stop use and ask 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poision Control Center right away

INDICATIONS & USAGE

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

STORAGE AND HANDLING

Other information

• store between 20°C and 25°C (68°F and 77°F)

INACTIVE INGREDIENT

Inactive ingredients

methylparaben, mineral oil, petrolatum, polxoxyl 40 stearate, propylparaben

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

Foodhold, U.S.A., LLC

Landover, MD 20785

1-877-846-9949

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREONE ORIGINAL STRENGTH TRIPLE ANTIBIOTIC 
bacitracin neomycin polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  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	50000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-312-14	1 in 1 CARTON	12/03/2018
1		14 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	09/16/2014

Labeler - Foodhold U.S.A. LLC (809183973)