Indications and uses
FOR THE TREATMENT AND PREVENTION OF ACNE PIMPLES.
FOR THE TREATMENT AND PREVENTION OF ACNE PIMPLES.
CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. START WITH 1 APPLICATION DAILY AND GRADUALLY INCREASE TO 2 TO 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. WHEN GOING OUTSIDE, USE A SUNSCREEN. ALLOW CREAM TO DRY AND FOLLOW DIRECTIONS IN THE SUNSCREEN LABELING. I...
KEEP CAP TIGHTLY CLOSED. STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F).
BENZOYL PEROXIDE 10%
ACNE MEDICATION
FOR THE TREATMENT AND PREVENTION OF ACNE PIMPLES.
FOR EXTERNAL USE ONLY. SUNSCREEN ALERT: AVOID UNNECESSARY SUNSCREEN EXPOSURE BY USING A SUNSCREEN.
YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO BENZOYL PEROXIDE OR IF YOU ARE TAKING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.
AVOID CONTACT WITH EYES, LIPS AND MOUTH. AVOID CONTACT WITH HAIR OR DYED FABRICS, INCLUDING CARPET AND CLOTHING WHICH MAY BE BLEACHED BY THIS PRODUCT. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.
SKIN IRRITATION, REDNESS, BURNING, ITCHING, PEELING OR SWELLING OCCURS AND LASTS. MILD IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.
IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. START WITH 1 APPLICATION DAILY AND GRADUALLY INCREASE TO 2 TO 3 TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. WHEN GOING OUTSIDE, USE A SUNSCREEN. ALLOW CREAM TO DRY AND FOLLOW DIRECTIONS IN THE SUNSCREEN LABELING. IF IRRITATION DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR.
KEEP CAP TIGHTLY CLOSED. STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F).
WATER (AQUA), C12-15 ALKYL BENZOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE, BENTONITE, LAURETH-7, CARBOMER, ALUMINUM HYDROXIDE, PEG-12, ISOPROPYL MYRISTATE, METHYLPARABEN, PROPYLPARABEN.
1-888-723-3929
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0321130745600 | GTIN-13: 0321130745600 EAN-13: 0321130745600 GTIN-12: 321130745600 UPC-A: 321130745600 GTIN storage (14 digits): 00321130745600 | atc01.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a46239a7-5963-4008-8cbb-6b9000f497eb | Product name | 1 | 20250721 |
| b382b4e1-6b48-45f6-bffc-e61b00b0ce19 | Product name | 3 | 20250317 |
| d9d61457-6a5a-41fc-b418-e5479a2904b7 | Product name | 2 | 20230303 |
| 32012d5c-25ac-49c7-9d4c-1313177fff7c | Product name | 1 | 20230112 |
| 13e7e7e3-e885-4c79-af6d-dad1aedbb06e | Product name | 1 | 20220128 |
| 4a7d44fe-774d-404b-aad0-8a90fe78375a | Product name | 4 | 20211025 |
| 3f45980c-c196-47e5-0e5e-48b7c57327c5 | Product name | 5 | 20200428 |
| d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b | Product name | 3 | 20200203 |
| ee5c6de5-d9cd-454f-b250-7b19e5cf2992 | Product name | 4 | 20190619 |
| ad75fcfd-a339-42a1-9c60-43ba2c654cfa | Product name | 1 | 20170810 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21130-826-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9805-f424-e053-dadaa90a57ce | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21130-826-01 | SAFEWAYACNE TREATMENT | 28 g in 1 TUBE | CREAM | 28 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOYL PEROXIDE | ACTIVE INGREDIENT | W9WZN9A0GM | 1 | |
| BENZOYL PEROXIDE | ACTIVE MOIETY | W9WZN9A0GM | 1 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| BENTONITE | INACTIVE INGREDIENT | A3N5ZCN45C | 1 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLYETHYLENE GLYCOL 600 | INACTIVE INGREDIENT | NL4J9F21N9 | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 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 |
|---|---|
| 21130-826 | 21130-826-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOYL PEROXIDE | W9WZN9A0GM | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALKYL (C12-15) BENZOATE | A9EJ3J61HQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| BENTONITE | A3N5ZCN45C | IACT |
| LAURETH-7 | Z95S6G8201 | IACT |
| CARBOMER 934 | Z135WT9208 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| ALUMINUM HYDROXIDE | 5QB0T2IUN0 | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | 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 |
|---|---|---|---|---|---|---|
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | SOLUTION / TOPICAL | 10 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | INJECTION / INTRAVENOUS | ADJ PH | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | GEL / TOPICAL | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TRANSDERMAL | 85 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OINTMENT / TOPICAL | 35 %w/w | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | GEL, METERED / TRANSDERMAL | 1 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SUSPENSION / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUPPOSITORY / VAGINAL | NA | ||
| BENTONITE | BENTONITE | A3N5ZCN45C | SUPPOSITORY / VAGINAL | 288.1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAVENOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| BENTONITE | BENTONITE | A3N5ZCN45C | LOTION / TOPICAL | 5 %w/w | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | OINTMENT / TOPICAL | 0.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 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 |
|---|---|---|---|---|---|---|
| 886e75dc-00ea-491f-89ed-1c9e5cc13e6a | 70222480-0ede-4516-a8cd-d6d61e0ca3de | 2012-06-11 | Warnings | 886e75dc-00ea-491f-89ed-1c9e5cc13e6a 70222480-0ede-4516-a8cd-d6d61e0ca3de |
Adverse event summaries are temporarily unavailable. Other product information remains available.