OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose
Benzocaine 20% .................................... Pain Reliever
Active Ingredient Purpose
Benzocaine 20% .................................... Pain Reliever
Uses
for the temporary relief of pain due to:
Keep out of reach of children. In case of overdose, get medical help immediately.
Directions
children under 12 years of age should be supervised in the use of this product. Adults and children 12 years of age and older:
Children under 2 years of age:
Teething Infants 4 months of age and over:
Infants under 4 months of age:
GERMA
Anesterm
Maximum Strength Oral Pain Reliever
20% Benzocaine PLUS Oil of Cloves
Fast Pain Relief
Easy To Apply
Warnings
Do not exceed recommended dosage.
Do not use
Stop use and ask a doctor if
These symptoms may be a sign of infection or a serious condition.
Inactive Ingredients
polyethylene glycol-75, polyethylene glycol-8, glycerin, propyl paraben, methyl paraben, sodium saccharin, clove oil
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1649341 | ANESGERM 20 % Oral Gel | PSN | 2 |
| 238910 | benzocaine 20 % Oral Gel | PSN | 2 |
| 1649341 | benzocaine 0.2 MG/MG Oral Gel [Anesgerm] | SBD | 2 |
| 238910 | benzocaine 0.2 MG/MG Oral Gel | SCD | 2 |
| 1649341 | Anesgerm 20 % Dental Gel | SY | 2 |
| 1649341 | Anesgerm 20 % Oral Gel | SY | 2 |
| 238910 | benzocaine 20 % (180-220 MG per 1 GM) Oral Gel | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10095-001-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ee0d-f424-e053-dadaa90a57ce | 982e6c46-37ab-419b-acea-521b3c356a7c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10095-001-01 | Anesgerm | 0.5 g in 1 PACKAGE | GEL | 0.5 | 2 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 2 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 2 | |
| CLOVE OIL | INACTIVE INGREDIENT | 578389D6D0 | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| POLYETHYLENE GLYCOL 1000 | INACTIVE INGREDIENT | U076Q6Q621 | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10095-001 | 10095-001-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| CLOVE OIL | 578389D6D0 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | 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 / INFILTRATION | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| POLYETHYLENE GLYCOL 1000 | POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | SUPPOSITORY / VAGINAL | NA | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| POLYETHYLENE GLYCOL 1000 | POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | AEROSOL, FOAM / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| POLYETHYLENE GLYCOL 1000 | POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | SUPPOSITORY / RECTAL | 1658 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SOLUTION / ORAL | 199 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4974 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w |
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 |
|---|---|---|---|---|---|---|
| 898632e8-9d4e-4a68-a5c7-ec62e33ca6ff | 982e6c46-37ab-419b-acea-521b3c356a7c | 2015-05-08 | Warnings | 898632e8-9d4e-4a68-a5c7-ec62e33ca6ff 982e6c46-37ab-419b-acea-521b3c356a7c |
Adverse event summaries are temporarily unavailable. Other product information remains available.