OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Benzocaine 5%
Benzalkonium Chloride .13%
Active Ingredient
Benzocaine 5%
Benzalkonium Chloride .13%
Purpose
External analgesic
Uses
▪ temporarily relieves itching
Warnings
For external use only
Avoid contact with eyes
Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Do not apply over large areas of the body
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away
Directions
Adults and children 2 years of age and older: Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor
Inactive Ingredients Purified water, Peg-400, Cetearyl Alcohol, Paraffinum Liquidum, Hydroxpropyl Bisstearyldimonium Chloride, Dimethicone, Glyceryl Stearate & Peg-100 Stearate, Diaziolidinyl Urea, Methyparaben, Propylparaben
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 27293-020-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c4d3-f6ea-e053-dbdaa90aa703 | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 27293-020-01 | BudpackFeminine Anti-itch | 1 in 1 BOX | CREAM | 1 | 1 | |
| 27293-020-21 | BudpackFeminine Anti-itch | 21 g in 1 TUBE | CREAM | 21 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZALKONIUM CHLORIDE | ACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| BENZALKONIUM | ACTIVE MOIETY | 7N6JUD5X6Y | 1 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE | INACTIVE INGREDIENT | OVB1E9X12I | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 27293-020 | 27293-020-21, 27293-020-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| WATER | 059QF0KO0R | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE | OVB1E9X12I | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| PEG-100 STEARATE | YD01N1999R | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| METHYLPARABEN | A2I8C7HI9T | 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 | INJECTION / INTRAVENOUS | 95 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAMUSCULAR | 406 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, EXTENDED RELEASE / ORAL | 17 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | GRANULE, FOR SUSPENSION / ORAL | 4 mg | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / VAGINAL | 100 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUPPOSITORY / RECTAL | 35 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, DELAYED RELEASE / ORAL | 15 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LOTION / TOPICAL | 5 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SWAB / TOPICAL | 5250 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / RECTAL | 0.25 mg/mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SPRAY, METERED / NASAL | 320 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 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 |
|---|---|---|---|---|---|---|
| 71d5322a-77bd-4bbb-a7be-0a4eb5f84756 | 1bbe74cc-f561-4597-b519-33cc51fad6b6 | 2012-05-01 | Warnings | 71d5322a-77bd-4bbb-a7be-0a4eb5f84756 1bbe74cc-f561-4597-b519-33cc51fad6b6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.