OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Dimethicone 1.25%
Active Ingredient
Dimethicone 1.25%
Purpose
Skin protectant
Uses
■Helps prevent and temporarily protects chafed, chapped, or cracked skin
■Helps prevent and protect from the drying effects of wind and cold weather
Warnings
For external use only
When using this product
■Do not get into eyes
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.
Do not use on
■Deep or puncture wounds
■Animal bites
■Serious burns
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions Apply as needed
Inactive ingredients avena sativa (oat) kernel flour, benzyl alcohol, ceteareth-20, cetrimonium chloride, cetyl alcohol, FD&C blue no.1, FD&C yellow no.5, FD&C yellow no.6, glycerin, isopropyl palmitate, methylchloroisothiazolinone, methylisothiazolinone, petrolatum, triethanolamine, water
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 46994-500-12 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e1d7-cd31-e053-dbdaa90ab51a | a17ce9e2-ed2e-4ed5-b815-108bf70fd350 |
| 46994-500-18 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e1d7-cd31-e053-dbdaa90ab51a | a17ce9e2-ed2e-4ed5-b815-108bf70fd350 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIMETHICONE | ACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIMETHICONE | ACTIVE MOIETY | 92RU3N3Y1O | 1 | |
| AVENA SATIVA FLOWERING TOP | INACTIVE INGREDIENT | MA9CQJ3F7F | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 1 | |
| CETRIMONIUM CHLORIDE | INACTIVE INGREDIENT | UC9PE95IBP | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 1 | |
| METHYLCHLOROISOTHIAZOLINONE | INACTIVE INGREDIENT | DEL7T5QRPN | 1 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 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 |
|---|---|
| 46994-500 | 46994-500-12, 46994-500-18 |
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 |
|---|---|---|---|---|---|---|
| TROLAMINE | TROLAMINE | 9O3K93S3TK | EMULSION / TOPICAL | 0.5 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUSPENSION / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | AEROSOL, SPRAY / TOPICAL | 397 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | MOUTHWASH / BUCCAL | 0.01 mg/1ml | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TOPICAL | 20 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRAMUSCULAR | 1000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAVENOUS | 400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | DROPS / NASAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SHAMPOO / TOPICAL | 1.25 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / SOFT TISSUE | 40 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SPRAY, METERED / NASAL | 5 mg/1ml | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | FILM / TRANSDERMAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / TOPICAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CAPSULE, DELAYED RELEASE / ORAL | 59 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / ORAL | 60.02 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAVENOUS | 242 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER / ORAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | OINTMENT / TOPICAL | 2.2 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | FILM / SUBLINGUAL | 0.03 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / RECTAL | 124 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | GEL / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRACAVITARY | 0.01 ml | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CAPSULE, EXTENDED RELEASE / ORAL | 0.26 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 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 |
|---|---|---|---|---|---|---|
| 6566ae73-8322-4254-85cb-a1bcdf46dbab | a17ce9e2-ed2e-4ed5-b815-108bf70fd350 | 2013-02-18 | Warnings | 6566ae73-8322-4254-85cb-a1bcdf46dbab a17ce9e2-ed2e-4ed5-b815-108bf70fd350 |
Adverse event summaries are temporarily unavailable. Other product information remains available.