TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
Available from:
Kareway Product, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
First aid antibiotic First aid antibiotic First aid antibiotic First aid to help prevent infection in minor: - cuts - scrapes - burns
Authorization status:
OTC monograph final
Authorization number:
67510-0631-1

TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b ointment

Kareway Product, 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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Soundbody Triple Antibiotic Ointment

Active ingredient

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purpos e

First aid antibiotic

First aid antibiotic

First aid antibiotic

Us es

First aid to help prevent infection in minor:

cuts

scrapes

burns

Warnings

For external use only.

Do not use

If you are allergic to any of the ingredients

When using this product

do not use in the eyes

do not apply over large areas of the body

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.

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

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 15° to 25°C (59° to 77°F)

Inactive ingredients

cetyl alcohol, mineral oil, petrolatum, squalane, stearic acid, tocopheryl acetate

Package label panel

Triple Antibiotic Ointment

TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin sulfate, polymyxin b ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7510 -0 6 31

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)

BACITRACIN

40 0 [USP'U] in 1 g

NEO MYCIN SULFATE (UNII: 0 57Y6 26 6 9 3) (NEOMYCIN - UNII:I16 QD7X29 7)

NEOMYCIN

3.5 mg in 1 g

PO LYMYXIN B SULFATE (UNII: 19 371312D4) (POLYMYXIN B - UNII:J2VZ0 7J9 6 K)

POLYMYXIN B

50 0 0 [USP'U] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

MINERAL O IL (UNII: T5L8 T28 FGP)

SQ UALANE (UNII: GW8 9 575KF9 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

PETRO LATUM (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7510 -0 6 31-1

1 in 1 BOX

12/12/20 13

1

28 .3 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Kareway Product, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333B

12/12/20 13

Labeler -

Kareway Product, Inc. (121840057)

Revised: 4/2019

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