Antibiotic Cream+pain Relief

SPL v2

SPL

SPL Set ID f7aa9330-c47c-4d2f-b784-11b831d919d6

Route

TOPICAL

Published

Effective Date 2024-01-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Neomycin (3.5 mg) Polymyxin B (10000 [USP'U]) Pramoxine (10 mg)

Inactive Ingredients

Methylparaben Mineral Oil Propylene Glycol Water White Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-24

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

first aid to help prevent infection and for the 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.

Section 55105-1

Active ingredients (each gram contains)	Purpose
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCl 10 mg	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

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

Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Other Information

store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredients

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

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

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Principal Display Panel 14.2 G Tube Carton

Foster & Thrive™

MAXIMUM STRENGTH

Antibiotic Cream + Pain Relief

Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM

NET WT ½ oz (14.2 g)

Structured Label Content

Uses

first aid to help prevent infection and for the 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.

Section 55105-1 (55105-1)

Active ingredients (each gram contains)	Purpose
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCl 10 mg	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 (Do not use)

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

Questions?

call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

Other Information (Other information)

store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum

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

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 14.2 G Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton)

Foster & Thrive™

MAXIMUM STRENGTH

Antibiotic Cream + Pain Relief

Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM

NET WT ½ oz (14.2 g)

Advanced Ingredient Data

[{"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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"}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help prevent infection and for the 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.", "55105-1": "Active ingredients (each gram contains) Purpose Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine HCl 10 mg 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": "in the eyes over large areas of the body if you are allergic to any of the ingredients", "Questions?": "call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST", "Other information": "store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date", "Inactive ingredients": "emulsifying wax, methylparaben, mineral oil, propylene glycol, purified water, white petrolatum", "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", "Ask a doctor before use if you have": "deep or puncture wounds animal bites serious burns", "PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton": "Foster & Thrive™ MAXIMUM STRENGTH Antibiotic Cream + Pain Relief Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl FIRST AID ANTIBIOTIC / PAIN RELIEVING CREAM NET WT ½ oz (14.2 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:30.642690 · Updated: 2026-03-14T23:09:19.585027