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:
REJOICE INTERNATIONAL INC.
48325 BINGHAMPTON DR.,
NORTHVILLE, MI 48168 USA
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 |
|---|---|---|---|---|---|
| 58503-037-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6eb6-111a-e063-dadaa90a10e2 | XtraCare Skin Relief Oatmeal Daily Moisturizing |
| 58503-037-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6eb6-111a-e063-dadaa90a10e2 | XtraCare Skin Relief Oatmeal Daily Moisturizing |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58503-037-01 | XtraCare Skin Relief Oatmeal Daily Moisturizing | 354 mg in 1 BOTTLE | LOTION | 354 | 3 | |
| 58503-037-02 | XtraCare Skin Relief Oatmeal Daily Moisturizing | 227 mg in 1 BOTTLE | LOTION | 227 | 3 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIMETHICONE | ACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| DIMETHICONE | ACTIVE MOIETY | 92RU3N3Y1O | 2 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 2 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 2 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 2 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 2 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| OAT | INACTIVE INGREDIENT | Z6J799EAJK | 2 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 2 | |
| POLYACRYLAMIDE (1500 MW) | INACTIVE INGREDIENT | 5D6TC4BRWV | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58503-037 | 58503-037-01, 58503-037-02 |
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 |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / IONTOPHORESIS | 0.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM, EXTENDED RELEASE / TRANSDERMAL | 20.4 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 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 |
|---|---|---|---|---|---|---|
| 92625a2f-73f0-ad7e-e053-2995a90ab785 | a230af2d-930f-4a91-921e-b82213af645f | 2019-09-12 | Warnings | 92625a2f-73f0-ad7e-e053-2995a90ab785 a230af2d-930f-4a91-921e-b82213af645f |
Adverse event summaries are temporarily unavailable. Other product information remains available.