Indications and uses
Helps treat and prevent diaper rash Prevents chafed skin due to diaper rash Helps seal out wetness
Helps treat and prevent diaper rash Prevents chafed skin due to diaper rash Helps seal out wetness
Change wet or soiled diapers promptly Clean the diaper area and allow to dry Apply iubtnebt liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.
Drug Facts
Zinc Oxide 16%
Skin Protectant
For external use only.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
boric acid, castor ol, fragrance, microcrystalline wax, mineral oil, paraffin, petrolatum
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58180-104-01 | 2020-04-07 | C162847 | 48780-1 | 9d75b9cf-e261-f424-e053-dadaa90a57ce | Diaper Rash |
| 58180-104-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e261-f424-e053-dadaa90a57ce | Diaper Rash |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | 1 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58180-104 | 58180-104-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| BORIC ACID | R57ZHV85D4 | IACT |
| CASTOR OIL | D5340Y2I9G | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PARAFFIN | I9O0E3H2ZE | 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 |
|---|---|---|---|---|---|---|
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | SOLUTION / TOPICAL | 1.38 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, COATED / ORAL | 0.9 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / SUBLINGUAL | 1.6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | EMULSION / OPHTHALMIC | 32 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET / ORAL | 17 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, EXTENDED RELEASE / ORAL | 321 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, FILM COATED / ORAL | 15.29 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | CAPSULE / ORAL | 1.04 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, EXTENDED RELEASE / ORAL | 23.27 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET / ORAL | 0.7 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | JELLY / VAGINAL | 1 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | GRANULE, FOR SUSPENSION / ORAL | 128 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | INJECTION, SOLUTION / INTRAVENOUS | 210 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | MOUTHWASH / BUCCAL | 7.36 mg/1ml | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | GEL / TOPICAL | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / RECTAL | 38 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION, SOLUTION / INTRAMUSCULAR | 525 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SHAMPOO / TOPICAL | 2 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / TOPICAL | 2860 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CREAM / TOPICAL | 300 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SUSPENSION/ DROPS / AURICULAR (OTIC) | 3 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | OINTMENT / TOPICAL | 14.9 %w/w | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SUSPENSION / AURICULAR (OTIC) | 0.6 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| CASTOR OIL | CASTOR OIL | D5340Y2I9G | INJECTION / INTRAMUSCULAR | 885 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CAPSULE, EXTENDED RELEASE / ORAL | 100 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SOLUTION/ DROPS / OPHTHALMIC | 48 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | SOAP / TOPICAL | 0.4 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, COATED / ORAL | 0.07 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w |
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 |
|---|---|---|---|---|---|---|
| 3e4c3f67-65f7-4efc-b858-719b92f93f18 | 60d7ca46-1a3f-42eb-a87f-b2848e56404f | 2020-04-08 | Warnings | 3e4c3f67-65f7-4efc-b858-719b92f93f18 60d7ca46-1a3f-42eb-a87f-b2848e56404f |
Adverse event summaries are temporarily unavailable. Other product information remains available.