OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose
Dimethicone 1/3% ...... Skin Protectant
Active Ingredient Purpose
Dimethicone 1/3% ...... Skin Protectant
XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion
dimethicone skin protectant
with soothing oat essence
To Protect & Relieve Dry Skin
12 fl oz (354 mL)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Use help prevent and temporarily protets chafed, chapped, or cracked skin.
Warnings For external use only.
When using this product avoid contact with eyes. In case of eye contact, flush with water.
Stop use and ask a doctor if condition worsens. Symptoms last more than 7 days or clear up and occur again within a few days.
Directions apply liberally as often as needed.
Other information Store at room temperature.
DISTRIBUTED BY:
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
MADE IN CHINA
Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33992-0054-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53fa-111a-e063-dadaa90a10e2 | XtraCare Skin Relief Oatmeal Daily Moisturizing |
| 33992-0054-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-53fa-111a-e063-dadaa90a10e2 | XtraCare Skin Relief Oatmeal Daily Moisturizing |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33992-0054-1 | XtraCare Skin Relief Oatmeal Daily Moisturizing | 227 mg in 1 BOTTLE | LOTION | 227 | 2 | |
| 33992-0054-2 | XtraCare Skin Relief Oatmeal Daily Moisturizing | 354 mg in 1 BOTTLE | LOTION | 354 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 33992-0054 | XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING (DIMETHICONE) LOTION [GREENBRIER INTERNATIONAL] | 2 | Legacy NDC, 2 package rows | 20190418_89de7426-6624-44fc-8f3a-f5a56f0d0262.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIMETHICONE | ACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIMETHICONE | ACTIVE MOIETY | 92RU3N3Y1O | 1 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 1 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| POLYACRYLAMIDE (1500 MW) | INACTIVE INGREDIENT | 5D6TC4BRWV | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 33992-0054 | 33992-0054-2, 33992-0054-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PEG-100 STEARATE | YD01N1999R | IACT |
| POLYACRYLAMIDE (1500 MW) | 5D6TC4BRWV | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| OAT | Z6J799EAJK | IACT |
| DMDM HYDANTOIN | BYR0546TOW | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| C13-14 ISOPARAFFIN | E4F12ROE70 | IACT |
| LAURETH-7 | Z95S6G8201 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
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 |
|---|---|---|---|---|---|---|
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SUSPENSION / AURICULAR (OTIC) | 0.02 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, DELAYED RELEASE / ORAL | 100 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAVENOUS | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 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 |
|---|---|---|---|---|---|---|
| 86bd4ea3-2271-4af4-e053-2991aa0a1f1b | 89de7426-6624-44fc-8f3a-f5a56f0d0262 | 2019-04-17 | Warnings | 86bd4ea3-2271-4af4-e053-2991aa0a1f1b 89de7426-6624-44fc-8f3a-f5a56f0d0262 |
Adverse event summaries are temporarily unavailable. Other product information remains available.