Indications and uses
HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH. HELPS SEAL OUT WETNESS.
HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH. HELPS SEAL OUT WETNESS.
CHANGE WET AND SOILED DIAPERS PROMPTLY. CLEAN THE DIAPER AREA AND ALLOW TO DRY. APPLY OINTMENT LIBERALLY AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.
STORE BETWEEN 20-25C (68-77F).
ZINC OXIDE 40%
SKIN PROTECTANT
HELPS TREAT AND PREVENT DIAPER RASH. PROTECTS CHAFED SKIN DUE TO DIAPER RASH. HELPS SEAL OUT WETNESS.
FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES.
CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS.
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
CHANGE WET AND SOILED DIAPERS PROMPTLY. CLEAN THE DIAPER AREA AND ALLOW TO DRY. APPLY OINTMENT LIBERALLY AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.
STORE BETWEEN 20-25C (68-77F).
BHA, COD LIVER OIL, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), LANOLIN, PETROLATUM, PHENOXYETHANOL, TALC, WATER (AQUA).
CALL 1-800-910-6874
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11673-334-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5b33-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-334-04 | UP and UPDIAPER RASH | 113.3 g in 1 TUBE | OINTMENT | 113.3 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 1 | |
| COD LIVER OIL | INACTIVE INGREDIENT | BBL281NWFG | 1 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11673-334 | 11673-334-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| COD LIVER OIL | BBL281NWFG | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| TALC | 7SEV7J4R1U | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION / INTRAVENOUS | NA | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SOLUTION / ORAL | 5 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE / ORAL | 729 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE / ORAL | 4 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / VAGINAL | 0.03 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | LOTION / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE, LIQUID FILLED / ORAL | 4 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SYRUP / ORAL | 1 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, FILM COATED / ORAL | 0.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / VAGINAL | 0.02 %w/w | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / TOPICAL | 2 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / SUBLINGUAL | 2 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GEL / TOPICAL | 7 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | FILM / SUBLINGUAL | 0.08 mg |
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 |
|---|---|---|---|---|---|---|
| 8f5f8e5f-06da-4888-9bcd-51b216608bf4 | ae6fbc43-083e-4035-bcfa-2aaddfbaeb33 | 2012-04-23 | Warnings | 8f5f8e5f-06da-4888-9bcd-51b216608bf4 ae6fbc43-083e-4035-bcfa-2aaddfbaeb33 |
Adverse event summaries are temporarily unavailable. Other product information remains available.