OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT:
SHEA BUTTER 99.5%
ACTIVE INGREDIENT:
SHEA BUTTER 99.5%
PURPOSE:
SKIN PROTECTANT
USES:
TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO
WARNING:
FOR EXTERNAL USE ONLY.
STOP USE AND ASK A DOCTOR IF
WHEN USING THIS PRODUCT
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
INACTIVE INGREDIENTS
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61515-103-13 | 2023-10-04 | C162847 | 48780-1 | 9855e2a2-49ef-60a7-e053-dbdaa90a05bd | 1a45abc8-05b7-4380-bf5d-209028a1111e |
| 61515-103-18 | 2023-10-04 | C162847 | 48780-1 | 9855e2a2-49ef-60a7-e053-dbdaa90a05bd | 1a45abc8-05b7-4380-bf5d-209028a1111e |
| 61515-103-13 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-49ef-60a7-e053-dbdaa90a05bd | 1a45abc8-05b7-4380-bf5d-209028a1111e |
| 61515-103-18 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-49ef-60a7-e053-dbdaa90a05bd | 1a45abc8-05b7-4380-bf5d-209028a1111e |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SHEA BUTTER | ACTIVE INGREDIENT | K49155WL9Y | 2 | |
| SHEA BUTTER | ACTIVE MOIETY | K49155WL9Y | 2 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61515-103 | 61515-103-13, 61515-103-18 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SHEA BUTTER | K49155WL9Y | ACTIB |
| TOCOPHEROL | R0ZB2556P8 | 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 |
|---|---|---|---|---|---|---|
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | INJECTION, EMULSION / INTRAVENOUS | 0.02 %w/v | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | 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 |
|---|---|---|---|---|---|---|
| 06e57e09-9dc2-f800-e063-6394a90a2cb8 | 1a45abc8-05b7-4380-bf5d-209028a1111e | 2023-10-04 | Warnings | 1a45abc8-05b7-4380-bf5d-209028a1111e |
Adverse event summaries are temporarily unavailable. Other product information remains available.