OTC - ACTIVE INGREDIENT SECTION
Active Ingredient:
SULFUR (3%)
Active Ingredient:
SULFUR (3%)
Purpose:
ACNE TREATMENT
Uses:
Warning:
For external use only
When Using This Product
Stop use and ask a doctor if
KEEP OUT OF REACH OF CHILDREN.
Directions:
Inactive Ingredient:
MICA, BISMUTH OXYCHLORIDE, ALUMINUM STARCH OCTENYLSUCCINATE, PARAFFINIUM LIQUIDUM (MINERAL OIL), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, SODIUM DEHYDROACETATE. MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76354-205-21 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3db9-60a7-e053-dbdaa90a05bd | 7d48561b-06e9-4fdd-89c2-6e9deb7bd19b |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76354-205-21 | MINERAL BLEMISH KIT | 3.3 g in 1 BOX | POWDER | 3.3 | 3 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SULFUR | ACTIVE INGREDIENT | 70FD1KFU70 | 3 | |
| SULFUR | ACTIVE MOIETY | 70FD1KFU70 | 3 | |
| ALUMINUM STARCH OCTENYLSUCCINATE | INACTIVE INGREDIENT | I9PJ0O6294 | 3 | |
| BISMUTH OXYCHLORIDE | INACTIVE INGREDIENT | 4ZR792I587 | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 3 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 3 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 3 | |
| SODIUM DEHYDROACETATE | INACTIVE INGREDIENT | 8W46YN971G | 3 | |
| TEA TREE OIL | INACTIVE INGREDIENT | VIF565UC2G | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76354-205 | 76354-205-21 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SULFUR | 70FD1KFU70 | ACTIB |
| MICA | V8A1AW0880 | IACT |
| BISMUTH OXYCHLORIDE | 4ZR792I587 | IACT |
| ALUMINUM STARCH OCTENYLSUCCINATE | I9PJ0O6294 | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| TEA TREE OIL | VIF565UC2G | IACT |
| SODIUM DEHYDROACETATE | 8W46YN971G | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | 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 |
|---|---|---|---|---|---|---|
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | SUSPENSION / ORAL | 6 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| ALUMINUM STARCH OCTENYLSUCCINATE | ALUMINUM STARCH OCTENYLSUCCINATE | I9PJ0O6294 | CREAM / TOPICAL | 321 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 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 |
|---|---|---|---|---|---|---|
| 17074116-d927-4be7-8556-458e2417165f | 7d48561b-06e9-4fdd-89c2-6e9deb7bd19b | 2014-03-19 | Warnings | 17074116-d927-4be7-8556-458e2417165f 7d48561b-06e9-4fdd-89c2-6e9deb7bd19b |
Adverse event summaries are temporarily unavailable. Other product information remains available.