Indications and uses
FOR THE TREATMENT OF ACNE
FOR THE TREATMENT OF ACNE
CLEANSE SKIN THOROUGHLY MOISTEN A COTTON BALL WITH PRODUCT AND COVER AFFECTED AREA ONE TO THREE TIMES DAILY DUE TO EXCESSIVE DRYING OF THE SKIN, START WITH ONE APPLICATION DAILY, INCREASING TO 2 OR 3 IF NEEDED OR AS DIRECTED BY A PHYSICIAN IF PEELING OCCURS, REDUCE USE TO ONCE A DAY OR EVERY OTHER DAY
STORE AT ROOM TEMPERATURE
SALICYLIC ACID 2.0%
ACNE TREATMENT
FOR THE TREATMENT OF ACNE
FOR EXTERNAL USE ONLY
USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. iF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR
AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER
IRRITATION OR REDNESS DEVELOPS AND LASTS
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
STORE AT ROOM TEMPERATURE
WATER (AQUA), ALCOHOL DENAT., ISOCETETH-20, FRAGRANCE (PARFUM), DIMETHICONE PROPYL PG-BETAINE, BENZOPHENONE-4, RED 4 (CI 14700), DENATONIUM BENZOATE
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55910-101-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2dd3-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-101-08 | DG BODYTONIC | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SALICYLIC ACID | ACTIVE INGREDIENT | O414PZ4LPZ | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| DENATONIUM BENZOATE | INACTIVE INGREDIENT | 4YK5Z54AT2 | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| ISOCETETH-20 | INACTIVE INGREDIENT | O020065R7Z | 1 | |
| SULISOBENZONE | INACTIVE INGREDIENT | 1W6L629B4K | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55910-101 | 55910-101-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SALICYLIC ACID | O414PZ4LPZ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| ISOCETETH-20 | O020065R7Z | IACT |
| SULISOBENZONE | 1W6L629B4K | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| DENATONIUM BENZOATE | 4YK5Z54AT2 | 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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| DENATONIUM BENZOATE | DENATONIUM BENZOATE | 4YK5Z54AT2 | SOLUTION / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| DENATONIUM BENZOATE | DENATONIUM BENZOATE | 4YK5Z54AT2 | SWAB / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / DENTAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %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 |
|---|---|---|---|---|---|---|
| b502d291-96d8-436b-afd9-5ca104f879aa | e9c1703f-840b-4ec1-960a-71c20dfb82ba | 2015-03-03 | Warnings | b502d291-96d8-436b-afd9-5ca104f879aa e9c1703f-840b-4ec1-960a-71c20dfb82ba |
Adverse event summaries are temporarily unavailable. Other product information remains available.