dolgencorp, llc triple antibiotic drug facts

SPL v3

SPL

SPL Set ID 4c97dada-966f-4de8-b5d9-e939cb456aea

Route

topical

Published

Effective Date 2024-11-06

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

cocoa butter olive oil petrolatum sodium pyruvate cottonseed oil .alpha.-tocopherol acetate

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

otc monograph drug active Since 2020-01-06

Purpose

First aid antibiotic External analgesic

Description

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

Medication Information

Warnings

For external use only.

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

•
cuts
•
scrapes
•
burns

Purpose

First aid antibiotic

External analgesic

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 20-25^°C (68-77^°F)

Inactive Ingredients

cocoa butter, cottonseed oil, olive oil, petrolatum, sodium pyruvate, tocopheryl acetate

Description

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

Do Not Use

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

Questions Or Comments?

1-888-309-9030

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).

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

Ask A Doctor Before Use If You Have

•
deep or puncture wounds
•
animal bites
•
serious burns

Package/label Principal Display Panel

DG™ | health

Compare to the active ingredients of Neosporin^® + Pain Itch Scar

First Aid Antibiotic/Pain Relieving Ointment

Triple Antibiotic

Bacitracin Zinc – Neomycin Sulfate

Polymyxin B Sulfate – Pramoxine HCl

+ PAIN • ITCH • SCAR

• Multi-Action Ointment

• Maximum Strength Pain and Itch Relief

• Minimizes the Appearance of Scars

Powerful Pain and Itch Relief for Cuts, Scrapes, and Burns

NET WT 1 OZ (28 g)

Structured Label Content

Warnings

For external use only.

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

•
cuts
•
scrapes
•
burns

Purpose

First aid antibiotic

External analgesic

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 (Other information)

•
store at 20-25^°C (68-77^°F)

Inactive Ingredients (Inactive ingredients)

cocoa butter, cottonseed oil, olive oil, petrolatum, sodium pyruvate, tocopheryl acetate

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

1-888-309-9030

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Active Ingredients (in Each Gram) (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

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

•
deep or puncture wounds
•
animal bites
•
serious burns

Package/label Principal Display Panel (Package/Label Principal Display Panel)

DG™ | health

Compare to the active ingredients of Neosporin^® + Pain Itch Scar

First Aid Antibiotic/Pain Relieving Ointment

Triple Antibiotic

Bacitracin Zinc – Neomycin Sulfate

Polymyxin B Sulfate – Pramoxine HCl

+ PAIN • ITCH • SCAR

• Multi-Action Ointment

• Maximum Strength Pain and Itch Relief

• Minimizes the Appearance of Scars

Powerful Pain and Itch Relief for Cuts, Scrapes, and Burns

NET WT 1 OZ (28 g)

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PYRUVATE", "unii": "POD38AIF08", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COTTONSEED OIL", "unii": "H3E878020N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help prevent infection and for temporary relief of pain or discomfort in minor: • cuts • scrapes • burns", "Purpose": "First aid antibiotic External analgesic", "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 20-25 ° C (68-77 ° F)", "Inactive ingredients": "cocoa butter, cottonseed oil, olive oil, petrolatum, sodium pyruvate, tocopheryl acetate", "Questions or comments?": "1-888-309-9030", "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).", "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", "Ask a doctor before use if you have": "• deep or puncture wounds • animal bites • serious burns", "Package/Label Principal Display Panel": "DG™ | health Compare to the active ingredients of Neosporin ® + Pain Itch Scar First Aid Antibiotic/Pain Relieving Ointment Triple Antibiotic Bacitracin Zinc – Neomycin Sulfate Polymyxin B Sulfate – Pramoxine HCl + PAIN • ITCH • SCAR • Multi-Action Ointment • Maximum Strength Pain and Itch Relief • Minimizes the Appearance of Scars Powerful Pain and Itch Relief for Cuts, Scrapes, and Burns NET WT 1 OZ (28 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:16.978095 · Updated: 2026-03-14T23:04:52.865909