Triple Antibiotic Ointment + Pain Relief

Triple Antibiotic Ointment + Pain Relief
SPL v2
SPL
SPL Set ID dfea6b2e-cd76-439d-a3da-64e2d8717163
Route
TOPICAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Neomycin (3.5 mg) Polymyxin B (10000 [USP'U]) Pramoxine (10 mg)
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

Description

Bacitracin zinc USP, 500 units Neomycin 3.5 mg Polymyxin B sulfate USP, 10,000 units Pramoxine hydrochloride USP, 10 mg

Purpose

First aid antibiotic Pain reliever


Medication Information

Purpose

First aid antibiotic Pain reliever

Description

Bacitracin zinc USP, 500 units Neomycin 3.5 mg Polymyxin B sulfate USP, 10,000 units Pramoxine hydrochloride USP, 10 mg

Uses

First aid to help prevent infection for the temporary relief of pain in minor ■ burns ■ cuts ■ scrapes

Purposes

First aid antibiotic

Pain reliever

Warnings

For external use only.



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

Do Not Use

■ if you are allergic to any of the ingredients

■ in the eyes

■ over large areas of the body

Other Information

■ store at 15°G to 30°C (59°F to 86°F)

■ before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient

white petrolatum

Questions Or Comments?

Call - 1-833-285-4151 Monday-Friday 9AM-5PM EST

Principal Display Panel

Triple Antibiotic

Ointment + Pain Relief

NET WT. 0.5 OZ (14 g)





Triple Antibiotic

Ointment + Pain Relief

NET WT. 1 OZ (28 g)

Stop Use and Ask Doctor If

■ you need to use longer than one week

■ condition persists or gets worse

■ rash or other allergic reaction develops 

■ symptoms persist for more than one week, or clear up and occur again within a few days

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each Gram)

Bacitracin zinc USP, 500 units

Neomycin 3.5 mg

Polymyxin B sulfate USP, 10,000 units

Pramoxine hydrochloride USP, 10 mg



Ask A Doctor Before Use If You Have

■ deeper puncture wounds

■ animal bites

■ serious bums


Structured Label Content

Uses

First aid to help prevent infection for the temporary relief of pain in minor ■ burns ■ cuts ■ scrapes

Purposes

First aid antibiotic

Pain reliever

Warnings

For external use only.



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

Do Not Use (Do not use)

■ if you are allergic to any of the ingredients

■ in the eyes

■ over large areas of the body

Other Information (Other information)

■ store at 15°G to 30°C (59°F to 86°F)

■ before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient (Inactive ingredient)

white petrolatum

Questions Or Comments? (Questions or comments?)

Call - 1-833-285-4151 Monday-Friday 9AM-5PM EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Triple Antibiotic

Ointment + Pain Relief

NET WT. 0.5 OZ (14 g)





Triple Antibiotic

Ointment + Pain Relief

NET WT. 1 OZ (28 g)

Stop Use and Ask Doctor If (Stop use and ask doctor if)

■ you need to use longer than one week

■ condition persists or gets worse

■ rash or other allergic reaction develops 

■ symptoms persist for more than one week, or clear up and occur again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc USP, 500 units

Neomycin 3.5 mg

Polymyxin B sulfate USP, 10,000 units

Pramoxine hydrochloride USP, 10 mg



Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ deeper puncture wounds

■ animal bites

■ serious bums


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)