Natureplex™ Antibiotic Ointment + Pain

SPL v2

SPL

SPL Set ID 317acec2-8ab7-4b62-9d72-f98cab4f979c

Route

TOPICAL

Published

Effective Date 2021-12-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [iU]) Neomycin (3.5 mg) Polymyxin B (10000 [iU]) Pramoxine (10 mg)

Inactive Ingredients

Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-12-14

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

cuts
scrapes
burns

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Warnings

For external use only.

Not for prolonged use.

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
the affected area may be covered with a sterile bandage

Children under 2 years of age: consult a doctor

Do Not Use

in the eyes, nose, or over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week unless directed by a doctor

Other Information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

petrolatum

Questions Or Comments?

866-323-0107 or www.natureplex.com

Stop Use and Ask A Doctor If

condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days
a rash, redness, irritation, swelling, or pain persists or increases, or other allergic reaction develops

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Principal Display Panel 28 G Tube Carton

Natureplex™

Antibiotic+

OINTMENT

Pain Relief

Bacitracin Zinc

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

NET WT 1 Oz (28g)

Structured Label Content

Uses

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

cuts
scrapes
burns

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each gram)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Warnings

For external use only.

Not for prolonged use.

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
the affected area may be covered with a sterile bandage

Children under 2 years of age: consult a doctor

Do Not Use (Do not use)

in the eyes, nose, or over large areas of the body
if you are allergic to any of the ingredients
longer than 1 week unless directed by a doctor

Other Information (Other information)

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients (Inactive ingredients)

petrolatum

Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

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

condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days
a rash, redness, irritation, swelling, or pain persists or increases, or other allergic reaction develops

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

deep or puncture wounds
animal bites
serious burns

Principal Display Panel 28 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28 g Tube Carton)

Natureplex™

Antibiotic+

OINTMENT

Pain Relief

Bacitracin Zinc

Neomycin Sulfate

Polymyxin B Sulfate

Pramoxine HCl

NET WT 1 Oz (28g)

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid to help prevent infection and temporary relief of pain or discomfort in minor: cuts scrapes burns", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each gram) Purpose Bacitracin zinc 500 units First aid antibiotic Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine hydrochloride 10 mg External analgesic", "Warnings": "For external use only. Not for prolonged use.", "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 the affected area may be covered with a sterile bandage Children under 2 years of age: consult a doctor", "Do not use": "in the eyes, nose, or over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor", "Other information": "store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.", "Inactive ingredients": "petrolatum", "Questions or comments?": "866-323-0107 or www.natureplex.com", "Stop use and ask a doctor if": "condition persists for more than 7 days, gets worse, or clears up and occurs again within a few days a rash, redness, irritation, swelling, or pain persists or increases, or other allergic reaction develops", "Ask a doctor before use if you have": "deep or puncture wounds animal bites serious burns", "PRINCIPAL DISPLAY PANEL - 28 g Tube Carton": "Natureplex™ Antibiotic+ OINTMENT Pain Relief Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate Pramoxine HCl NET WT 1 Oz (28g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:26.370635 · Updated: 2026-03-14T23:12:38.341862