lifelabs, a division of atico international usa, inc

lifelabs, a division of atico international usa, inc.

SPL v10

SPL

SPL Set ID db368653-fce9-4773-af14-08067409529f

Route

topical

Published

Effective Date 2010-08-23

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

mineral oil methylparaben polyoxyl 40 stearate propylparaben petrolatum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph final active Since 2010-11-01

Description

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

Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert:

do not use if allergic to any of the ingredients

Indications and Usage

Uses

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

Dosage and Administration

Directions

Adults and children 2 years and older:

clean affected area
may be covered with a sterile bandage
apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily.

Children under 2 years: ask a doctor

Description

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

Section 44425-7

Other information

store at 59^o - 86^oF (15^o - 30^oC)

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

condition lasts or gets worse
a rash or other allergic reaction occurs
symptoms last for more than 7 days or clear up and come back within a few days

Section 50569-3

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Section 50570-1

Do not use

in or near eyes
longer than 1 week
on large areas of the body

Section 51727-6

Inactive Ingredients

liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Section 51945-4

Section 53413-1

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

Section 55105-1

Purposes

First aid antibiotic
Pain reliever

First Aid Triple Antibiotic and Pain Relief (maximum Strength)

Active Ingredients

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert:

do not use if allergic to any of the ingredients

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

Directions

Adults and children 2 years and older:

clean affected area
may be covered with a sterile bandage
apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily.

Children under 2 years: ask a doctor

Section 44425-7 (44425-7)

Other information

store at 59^o - 86^oF (15^o - 30^oC)

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition lasts or gets worse
a rash or other allergic reaction occurs
symptoms last for more than 7 days or clear up and come back within a few days

Section 50569-3 (50569-3)

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Section 50570-1 (50570-1)

Do not use

in or near eyes
longer than 1 week
on large areas of the body

Section 51727-6 (51727-6)

Inactive Ingredients

liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

Section 55105-1 (55105-1)

Purposes

First aid antibiotic
Pain reliever

First Aid Triple Antibiotic and Pain Relief (maximum Strength) (First Aid Triple Antibiotic and Pain Relief (Maximum Strength))

Active Ingredients

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Advanced Ingredient Data

[{"name": "Bacitracin", "unii": "58H6RWO52I", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "Neomycin", "unii": "I16QD7X297", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Polymyxin B", "unii": "J2VZ07J96K", "classCode": "ACTIB", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "Pramoxine", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Mineral Oil", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Methylparaben", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polyoxyl 40 Stearate", "unii": "13A4J4NH9I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylparaben", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Petrolatum", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses First aid to help prevent infection in minor cuts, scrapes, and burns First aid for the temporary relief of pain in minor cuts, scrapes, and burns", "34068-7": "Directions Adults and children 2 years and older: clean affected area may be covered with a sterile bandage apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily. Children under 2 years: ask a doctor", "34071-1": "Warnings For external use only Allergy alert: do not use if allergic to any of the ingredients", "44425-7": "Other information store at 59 o - 86 o F (15 o - 30 o C)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if condition lasts or gets worse a rash or other allergic reaction occurs symptoms last for more than 7 days or clear up and come back within a few days", "50569-3": "Ask a doctor before use if you have deep or puncture wounds animal bites serious burns", "50570-1": "Do not use in or near eyes longer than 1 week on large areas of the body", "51727-6": "Inactive Ingredients liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum", "53413-1": "Questions? Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.", "55105-1": "Purposes First aid antibiotic Pain reliever", "First Aid Triple Antibiotic and Pain Relief (Maximum Strength)": "Active Ingredients Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units Pramoxine hydrochloride 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:09.325970 · Updated: 2026-03-14T22:52:30.292621