OTC - ACTIVE INGREDIENT SECTION
ARBUTIN 2.10g/100g
ARBUTIN 2.10g/100g
For external use only
Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.
Keep out of eyes. Rinse with water to remove.
Stop use if a rash or irritation develops and lasts.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1c9d1af-bddd-448d-86f7-69052b7d5b47 | Product name | 1 | 20220627 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53208-385-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cac5-621f-e053-dbdaa90a74ad | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53208-385-01 | ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION | 120 g in 1 CONTAINER | LOTION | 120 | 1 | |
| 53208-385-02 | ISAKNOX WHITE SYMPHONY BRIGHTENING EMULSION | 1 in 1 BOX | LOTION | 1 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ARBUTIN | ACTIVE INGREDIENT | C5INA23HXF | 1 | |
| ARBUTIN | ACTIVE MOIETY | C5INA23HXF | 1 | |
| 2-ETHYLHEXANOIC ACID | INACTIVE INGREDIENT | 01MU2J7VVZ | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| BETAINE | INACTIVE INGREDIENT | 3SCV180C9W | 1 | |
| CAPRIC ACID | INACTIVE INGREDIENT | 4G9EDB6V73 | 1 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | 1 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 1 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 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 |
|---|---|
| 53208-385 | 53208-385-01, 53208-385-02 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / TOPICAL | 2.6 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / TOPICAL | 1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | GEL, METERED / TRANSDERMAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, CHEWABLE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, CHEWABLE / ORAL | 4.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|
| 33a6f73b-4cc8-407a-8cf1-f07403a3284a | 7ced5492-9ef6-4c0b-b040-d5dae08e4501 | 2010-03-29 | Warnings | 33a6f73b-4cc8-407a-8cf1-f07403a3284a 7ced5492-9ef6-4c0b-b040-d5dae08e4501 |
Adverse event summaries are temporarily unavailable. Other product information remains available.