OTC - ACTIVE INGREDIENT SECTION
ARBUTIN 2.1mL/100mL
ARBUTIN 2.1mL/100mL
For external use only
Sooryehan
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53208-445-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c885-621f-e053-dbdaa90a74ad | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53208-445-01 | Sooryehan Pure-Whitening Essential Starter | 160 mL in 1 CONTAINER | CREAM | 160 | 1 | |
| 53208-445-02 | Sooryehan Pure-Whitening Essential Starter | 1 in 1 BOX | CREAM | 1 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARBUTIN | ACTIVE INGREDIENT | C5INA23HXF | 1 | |
| ARBUTIN | ACTIVE MOIETY | C5INA23HXF | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53208-445 | 53208-445-01, 53208-445-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ARBUTIN | C5INA23HXF | ACTIB |
| WATER | 059QF0KO0R | IACT |
| DIPROPYLENE GLYCOL | E107L85C40 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | 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 |
|---|---|---|---|---|---|---|
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / TOPICAL | 2.6 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / ORAL | 60.02 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPONGE / TOPICAL | 11 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE / ORAL | 652 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SHAMPOO / TOPICAL | 3.7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOLUTION / TOPICAL | NA | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CAPSULE, EXTENDED RELEASE / ORAL | 9.43 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / VAGINAL | 56 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.02 %w/v | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / ORAL | 180 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LIQUID / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED / ORAL | 0.03 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TRANSDERMAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TOPICAL | 20 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, SUGAR COATED / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / VAGINAL | 2 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOAP / TOPICAL | 0.08 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 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 |
|---|---|---|---|---|---|---|
| 5aa029cd-c6b4-422c-a8af-8b912a261df0 | 9d81c118-6c63-4a4b-995d-2dee6deba036 | 2010-05-13 | Warnings | 5aa029cd-c6b4-422c-a8af-8b912a261df0 9d81c118-6c63-4a4b-995d-2dee6deba036 |
Adverse event summaries are temporarily unavailable. Other product information remains available.