Equate™ First Aid Antibiotic+pain Relief Ointment

Equate™ First Aid Antibiotic+pain Relief Ointment
SPL v3
SPL
SPL Set ID 907d44c5-cbd1-4d13-8c5c-c164f7a536e5
Route
TOPICAL
Published
Effective Date 2024-12-31
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
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-18

Description

Drug Facts


Medication Information

Description

Drug Facts

Use

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 500 units First aid antibiotic
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.

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 Ingredient

petrolatum

Questions Or Comments?

1-888-287-1915

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

NDC 49035-840-01

equate™

Compare

Neosporin®

+ Pain Relief

Active

Ingredients*

Maximum Strength

First Aid

Antibiotic

+ Pain Relief

First Aid Antibiotic

Pain Relieving

Ointment

Bacitracin Zinc, Neomycin

Sulfate, Polymyxin B Sulfate,

Pramoxine HCl

  • Soothes painful cuts,

    scrapes and burns while

    preventing infection

NET WT 1 OZ (28g)


Structured Label Content

Use

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 500 units First aid antibiotic
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.

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 Ingredient (Inactive ingredient)

petrolatum

Questions Or Comments? (Questions or comments?)

1-888-287-1915

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)

NDC 49035-840-01

equate™

Compare

Neosporin®

+ Pain Relief

Active

Ingredients*

Maximum Strength

First Aid

Antibiotic

+ Pain Relief

First Aid Antibiotic

Pain Relieving

Ointment

Bacitracin Zinc, Neomycin

Sulfate, Polymyxin B Sulfate,

Pramoxine HCl

  • Soothes painful cuts,

    scrapes and burns while

    preventing infection

NET WT 1 OZ (28g)


Advanced Ingredient Data


Raw Label Data

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