9446375d-4bb4-4bb1-bdc2-c18e995bfe26

SPL v7
SPL
SPL Set ID 9446375d-4bb4-4bb1-bdc2-c18e995bfe26
Route
topical
Published
Effective Date 2019-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (6 mg) neomycin (3.5 mg) polymyxin b (0.77 mg)
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-02-25

Purpose

First Aid Antibiotics

Description

Drug Facts


Medication Information

Warnings

External use only.

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

First Aid

Antibiotics

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Inactive Ingredients

petrolatum

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Description

Drug Facts

Section 42229-5

Drug Facts

Do Not Use
  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Active Ingredient

(in each gram)

Bacitracin zinc 400 units

Neomycin sulfate (3.5 mg Neomycin) Polymyxin B sulfate 5000 units

Stop Use, Ask A Doctor
  • a rash or allergic reactions develops
  • condition worsens or persists
Keep Out of Reach of Children.

If ingested, contact a Poison Control Center right away.

Principal Display Panel Antibiotic Pouch Label

Welly™

Triple Antibiotic

Ointment

0.5g/ 1/57 OZ


Structured Label Content

Warnings

External use only.

Uses

First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

First Aid

Antibiotics

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage
Inactive Ingredients (Inactive ingredients)

petrolatum

Welly Health PBC, Minn., MN 55402

1-833-BE-WELLY

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)
  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Active Ingredient (Active ingredient)

(in each gram)

Bacitracin zinc 400 units

Neomycin sulfate (3.5 mg Neomycin) Polymyxin B sulfate 5000 units

Stop Use, Ask A Doctor (Stop use, ask a doctor)
  • a rash or allergic reactions develops
  • condition worsens or persists
Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested, contact a Poison Control Center right away.

Principal Display Panel Antibiotic Pouch Label (Principal Display Panel - Antibiotic Pouch Label)

Welly™

Triple Antibiotic

Ointment

0.5g/ 1/57 OZ


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)