INACTIVE INGREDIENT SECTION
Inactive Ingredients mineral oil, petrolatum
Inactive Ingredients mineral oil, petrolatum
Active Ingredient (in each gram)
Bacitracin 400 units
Neomycin 3.5 mg
Polymyxcin B 5,000 units
Purpose
First aid antibiotic
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses first aid to help prevent infection in minor:
-cuts
-scrapes
-burns
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 to affected area 1 to 3 times daily
-may be covered with a small bandage
Children under 2 years of age: ask a doctor before use
Stop use and ask a doctor if
-symptoms last for more than 7 days, the condition persists or gets worse
-symptoms clear up and then occur again within a few days
-a rahs or other allergic reaction occurs
Ask a doctor before use if you have
deep or puncture wounds
animal bites
serious burns
| Class | Version | Type | Effective |
|---|---|---|---|
| BACITRACIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NEOMYCIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POLYMYXIN B Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| 2d352c73-a357-4193-a4de-dfdf9a2ac8e4 | Product name | 1 | 20150819 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55621-002-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d835-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55621-002-01 | TheraPlusPlus Plus | 9 g in 1 TUBE | OINTMENT | 9 | 5 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BACITRACIN | ACTIVE INGREDIENT | 58H6RWO52I | 5 | |
| NEOMYCIN | ACTIVE INGREDIENT | I16QD7X297 | 5 | |
| POLYMYXIN B | ACTIVE INGREDIENT | J2VZ07J96K | 5 | |
| BACITRACIN | ACTIVE MOIETY | 58H6RWO52I | 5 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | 5 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | 5 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 5 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55621-002 | 55621-002-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BACITRACIN | 58H6RWO52I | ACTIB |
| NEOMYCIN | I16QD7X297 | ACTIB |
| POLYMYXIN B | J2VZ07J96K | ACTIB |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7031fcd6-ab38-4fd0-9188-8a20156aab96 | ea5c0c2a-883a-4713-838d-53e03f4cf798 | 2013-04-06 | Warnings | 7031fcd6-ab38-4fd0-9188-8a20156aab96 ea5c0c2a-883a-4713-838d-53e03f4cf798 |
Adverse event summaries are temporarily unavailable. Other product information remains available.