Storage and handling
Other Information: Store at room temperature 20-25C (68-77F)
Other Information: Store at room temperature 20-25C (68-77F)
Active Ingredient:
Salicylic Acid 2.0%
Purpose:
Anti-Acne
Uses:
For the treatment of acne
Helps prevent new acne blemishes
Warning:
For external use only
When Using This Product:
Keep out of eyes, rinse with water to remove.
With other tropical acne medications at the same time or immediately following use of this product may increase dryness or irritation to the skin. If this occurs, only one medication should be used unless directed by your doctor.
Tell Your Doctor And Pharmacist If
You are allergic to salicylic acid or any other medications
Keep Out of Reach of Children:
If swallowed get medical help or contact a Poison Control Center immediately
Directions:
Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Other Information:
Store at room temperature 20-25C (68-77F)
Inactive Ingredient:
Synthetic Beeswax, Microstalline Wax, Euphorbia Cerifera (Candelilla) Wax, Hydrogenated Castor Oil, Ethylhexy Palmitate, Paraffinium Liquidum (Mineral Oil), Bis-Diglyceryl Polyacyladipate-2, Isopropyl Myristate, Petrolatum, Mica, Melaleuca Alternafolia (Tea Tree) Leaf Oil, BHT, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone.lab
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76354-004-01 | 2019-12-20 | C162847 | 48780-1 | 97449f38-cc23-f6ea-e053-dbdaa90aa703 | Drug Fact |
| 76354-004-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-cc23-f6ea-e053-dbdaa90aa703 | Drug Fact |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SALICYLIC ACID | ACTIVE INGREDIENT | O414PZ4LPZ | 2 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 2 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 2 | |
| CAMPHOR OIL | INACTIVE INGREDIENT | 75IZZ8Y727 | 2 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 2 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 2 | |
| METHYLCHLOROISOTHIAZOLINONE | INACTIVE INGREDIENT | DEL7T5QRPN | 2 | |
| METHYLISOTHIAZOLINONE | INACTIVE INGREDIENT | 229D0E1QFA | 2 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 2 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 2 | |
| TEA TREE OIL | INACTIVE INGREDIENT | VIF565UC2G | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76354-004 | 76354-004-01 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / SUBLINGUAL | 0.13 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, SPRAY / TOPICAL | 6.89 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRASYNOVIAL | 18 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TRANSDERMAL | 113 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION / ORAL | 14 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / SUBCUTANEOUS | 225 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | GEL / TOPICAL | 185 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / VAGINAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE / ORAL | 3 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 8.4 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / ENDOTRACHEAL | 54 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, COATED / ORAL | 1 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | OINTMENT / TOPICAL | 3575 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, EXTENDED RELEASE / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OINTMENT / TOPICAL | 35 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 144 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| CANDELILLA WAX | CANDELILLA WAX | WL0328HX19 | TABLET, DELAYED RELEASE / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 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 |
|---|---|---|---|---|---|---|
| 10a9f4b2-4abc-4ffc-bec7-5592f007a85c | 9a2ee3ce-3a6a-47ef-834a-83b174ed5cd5 | 2012-04-18 | Warnings | 9a2ee3ce-3a6a-47ef-834a-83b174ed5cd5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.