OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose
Petrolatum 5% Skin Protectant
Active Ingredient Purpose
Petrolatum 5% Skin Protectant
Keep out of reach of children
Use daily, do not use around eye area
For external use only, Do not use around the eye area.Stop use and ask a doctor if redness or imitation develop and persist for more than 7 days
apply as needed
water, mineral oil, cetyl alcohol, glyceryl stearate, glycerin, dimethicone, propylene glycol, methylparaben, propylparaben, DMDM hydantoin, ammonium polyacrylate, steareth-30, tocopheryl acetate, cocoa butter, shea butter extract, fragrance, blue 1, red 33, yellow 5, yellow 6
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33992-1108-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ffd7-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33992-1108-1 | Cocoa Butter | 396.9 g in 1 BOTTLE, PLASTIC | LOTION | 396.9 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 33992-1108 | COCOA BUTTER (PETROLATUM ) LOTION [GREENBRIER INTERNATIONAL] | 1 | Legacy NDC, 1 package rows | 20110805_577d47c9-4a40-4994-9b62-974166375183.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| petrolatum | ACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| petrolatum | ACTIVE MOIETY | 4T6H12BN9U | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| cocoa butter | INACTIVE INGREDIENT | 512OYT1CRR | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 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 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| steareth-30 | INACTIVE INGREDIENT | 5776GCL1DG | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 33992-1108 | 33992-1108-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| petrolatum | 4T6H12BN9U | ACTIB |
| water | 059QF0KO0R | IACT |
| mineral oil | T5L8T28FGP | IACT |
| cetyl alcohol | 936JST6JCN | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| glycerin | PDC6A3C0OX | IACT |
| dimethicone | 92RU3N3Y1O | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| methylparaben | A2I8C7HI9T | IACT |
| propylparaben | Z8IX2SC1OH | IACT |
| steareth-30 | 5776GCL1DG | IACT |
| cocoa butter | 512OYT1CRR | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | 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 |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | ELIXIR / ORAL | 27.5 mg/5ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE / ORAL | 1 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, COATED / ORAL | 7.93 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | SYRUP / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| mineral oil | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| abe4d54d-b026-45d0-beda-2f36ffa0c4bd | 577d47c9-4a40-4994-9b62-974166375183 | 2011-08-02 | Warnings | abe4d54d-b026-45d0-beda-2f36ffa0c4bd 577d47c9-4a40-4994-9b62-974166375183 |
Adverse event summaries are temporarily unavailable. Other product information remains available.