OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Lidocaine HCl 0.5%
Phenol 0.5%
Active Ingredients
Lidocaine HCl 0.5%
Phenol 0.5%
Purpose
Topical Anesthetic
Antiseptic
Uses
Warnings
For external use only
Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.
Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases or if infection develops.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Other Information
Inactive Ingredients
Purified Water, Mineral Oil, Petrolatum, Cetearyl Alcohol, Glyceryl Stearate, Propylene Glycol, Stearic Acid, Methylparaben, Sorbitan Stearate, Polysorbate 60, Propylparaben, .
PRINCIPAL DISPLAY PANEL
Budpak First Aid Cream
Lidocaine HCl 0.5%
Phenol 0.5%
NET WT 1 OZ (28 g)
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 27293-016-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-96af-f424-e053-dadaa90a57ce | 40159073-39ca-4557-8478-8490fb6986ea |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27293-016-01 | Budpak First Aid | 1 in 1 BOX | CREAM | 1 | 1 | |
| 27293-016-28 | Budpak First Aid | 28 g in 1 TUBE | CREAM | 28 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | ACTIVE INGREDIENT | V13007Z41A | 1 | |
| PHENOL | ACTIVE INGREDIENT | 339NCG44TV | 1 | |
| LIDOCAINE | ACTIVE MOIETY | 98PI200987 | 1 | |
| PHENOL | ACTIVE MOIETY | 339NCG44TV | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 27293-016 | 27293-016-28, 27293-016-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIDOCAINE HYDROCHLORIDE | V13007Z41A | ACTIR |
| PHENOL | 339NCG44TV | ACTIB |
| WATER | 059QF0KO0R | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | 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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SHAMPOO / TOPICAL | 14.55 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / VAGINAL | 200 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | OINTMENT / TOPICAL | 2 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAMUSCULAR | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUSPENSION / ORAL | 62.5 mg/5ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / VAGINAL | 100 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 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 |
|---|---|---|---|---|---|---|
| 7f9aefd9-47cf-49cf-a1b2-b6a2b60695ea | 40159073-39ca-4557-8478-8490fb6986ea | 2013-06-12 | Warnings | 7f9aefd9-47cf-49cf-a1b2-b6a2b60695ea 40159073-39ca-4557-8478-8490fb6986ea |
Adverse event summaries are temporarily unavailable. Other product information remains available.