OTC - ACTIVE INGREDIENT SECTION
glycerine
glycerine
water, butylene glycol, panthenol etc
skin protectant
keep out of reach of the children
apply to the skin and rub gently and wash away
・Stop using the product when you have skin problems or the
product disagrees with your skin
・Stop using the product immediately and
consult a dermatologist if you have redness, swelling, itching or
irritation on the skin while or after using the product.
・Don't
place the product in any place where it will be subjected to extremely
high or low temperatures or direct sunlight.
for external use only
| Class | Version | Type | Effective |
|---|---|---|---|
| GLYCERIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69603-0801-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2c8f-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69603-0801-1 | SELLA NATURAL BABY | 120 mL in 1 BOTTLE | LOTION | 120 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69603-0801 | SELLA NATURAL BABY (GLYCERIN) LOTION [SELLA NATURAL COSMETICS CO.,LTD.] | 1 | Legacy NDC, 1 package rows | 20150211_28c0416f-0bd7-4088-834c-2a2dab7a244f.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| GLYCERIN | ACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERIN | ACTIVE MOIETY | PDC6A3C0OX | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69603-0801 | 69603-0801-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | ACTIB |
| WATER | 059QF0KO0R | IACT |
| BUTYLENE GLYCOL | 3XUS85K0RA | IACT |
| PANTHENOL | WV9CM0O67Z | 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 |
|---|---|---|---|---|---|---|
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 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 |
|---|---|---|---|---|---|---|
| 36f1cee4-1fa7-48aa-9a31-b2000ecd59e8 | 28c0416f-0bd7-4088-834c-2a2dab7a244f | 2015-02-11 | Warnings | 36f1cee4-1fa7-48aa-9a31-b2000ecd59e8 28c0416f-0bd7-4088-834c-2a2dab7a244f |
Adverse event summaries are temporarily unavailable. Other product information remains available.