OTC - ACTIVE INGREDIENT SECTION
Active Ingredients...........Purpose
Dimethicone 1%.............Skin Protectant
Active Ingredients...........Purpose
Dimethicone 1%.............Skin Protectant
Uses: protects from minor skin irritations.
Warnings: For external use only
Do not use
When using this product
Stop use and ask a doctor if:
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately
Directions:
Other ingredients: Water, Almond Oil, Glycerin, Cetearyl alcohol, Cetearteh-12, almond Oil, L-Carnitine, DMAE, Bitartrate, Sodium Ascorbyl Fosphate,, Sunflower Seed Oil, Green Tea extract, Coffee extract, Sodium Dodecyl Sulphate, Base Lemon Grass, Pepermint Oil, Menthol, Ultrex 21, Green Tea scent, EDTA, BHT, BHA.
8 fl oz / 240 fl ml
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 08c722ec-780f-bb7b-8f14-3d4f7bf0e098 | Product name | 2 | 20240205 |
| e2f276e5-439f-b432-b5e5-b0cfa993da69 | Product name | 3 | 20220609 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 4585a4fb-0028-3d95-020c-9b1c40bf15e0 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51439-003-01 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e0d2-cd31-e053-dbdaa90ab51a | 3259fef2-b2e2-40aa-b383-601d65e982c4 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51439-003-01 | Simply Firm - BodyGelcreme | .024 mg in 1 TUBE | GEL | .024 | 4 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dimethicone | ACTIVE INGREDIENT | 92RU3N3Y1O | 4 | |
| Dimethicone | ACTIVE MOIETY | 92RU3N3Y1O | 4 | |
| ALMOND | INACTIVE INGREDIENT | 3Z252A2K9G | 4 | |
| ALMOND OIL | INACTIVE INGREDIENT | 66YXD4DKO9 | 4 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | 4 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 4 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 4 | |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | 71DD5V995L | 4 | |
| CETEARETH-12 | INACTIVE INGREDIENT | 7V4MR24V5P | 4 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 4 | |
| DEANOL | INACTIVE INGREDIENT | 2N6K9DRA24 | 4 | |
| EDETIC ACID | INACTIVE INGREDIENT | 9G34HU7RV0 | 4 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 4 | |
| LEVOCARNITINE | INACTIVE INGREDIENT | 0G389FZZ9M | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 4 | |
| MINT | INACTIVE INGREDIENT | FV98Z8GITP | 4 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | 4 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 4 | |
| SODIUM ASCORBYL PHOSPHATE | INACTIVE INGREDIENT | 836SJG51DR | 4 | |
| SODIUM DODECYLBENZENESULFONATE | INACTIVE INGREDIENT | 554127163Y | 4 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 4 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 4 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 4 | |
| WEST INDIAN LEMONGRASS OIL | INACTIVE INGREDIENT | 5BIA40E9ED | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51439-003 | 51439-003-01 |
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 | INJECTION / PERIDURAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CONCENTRATE / ORAL | 6 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAMUSCULAR | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CONCENTRATE / ORAL | 2.5 mg/5ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SYRUP / ORAL | 1 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / RECTAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, SOLUTION / INFILTRATION | 0.2 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL, METERED / TOPICAL | 4 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / TOPICAL | 0.04 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / ORAL | 526 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | LOTION / TOPICAL | 1000 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET / ORAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SHAMPOO / TOPICAL | 3.7 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / VAGINAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, ORALLY DISINTEGRATING / ORAL | 9 mg | ||
| EDETIC ACID | EDETIC ACID | 9G34HU7RV0 | TABLET / ORAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CONCENTRATE / ORAL | 0.08 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SOLUTION / ORAL | 5 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET, FILM COATED / ORAL | 20 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v |
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 |
|---|---|---|---|---|---|---|
| 1ad3a24f-b2cb-4189-aa4c-b4670bc8d657 | 3259fef2-b2e2-40aa-b383-601d65e982c4 | 2013-04-23 | Warnings | 1ad3a24f-b2cb-4189-aa4c-b4670bc8d657 3259fef2-b2e2-40aa-b383-601d65e982c4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.