OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Benzoyl Peroxide 5% w/v
Active Ingredient
Benzoyl Peroxide 5% w/v
Purpose
Acne treatment
Use for the treatment of acne
Warnings - For external use only
Do not use if you are sensitive to Benzoyl Peroxide or have very sensitive skin.
This product may cause irritation. Ask a doctor or pharmacist before use if you
are using other topical acne medications at the same time or immediately
following use of this product. When using this product avoid contact with eyes.
If occurs flush thoroughly. Keep away from lips and mouth. Avoid excessive sun
exposure. Skin irritation may occur such as redness, burning, itching or
swelling. Irritation may be reduced by using less frequently or in a smaller dose.
Stop use and consult a doctor if irritation becomes severe.
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center immediately.
DIRECTIONS
• Before each use, wash skin with mild soap and allow to dry.
• Apply generously to pimples, brown spots, and aging skin. Use three to four times daily for one to three months for best results.
• Use twice daily to prevent acne from reappearing.
• Do not use with other acne creams, skin peels and treatments, or exfoliants.
• If bothersome irritation, drying, or skin peeling should occur, reduce frequency of use.
Inactive ingredients: Alkyl Benzoate, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Butylparaben, Diazolidinyl Urea, Ethyl Alcohol, Ethylparaben, Lactic Acid, Methyparaben, Niacinamide, Phenoxyethanol, Propylparaben, Sodium Metabisulfite, Sorbic Acid, Tocopheryl (Vitamin E), Water, Zinc Oxide
Other Information • Sensitivity test: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the stated directions.• Avoid contact with hair and
dyed fabrics, which may be bleached by this product.
AUGUSTUS BIOMED
All-in-One
Acne Cream + Moisturizer
with Vitamin E
Antibacterial and Pore Cleansing
With Benzoyl Peroxide
Evens Skin Tone
Mild exfoliant
Dark spot and fine wrinkle inhibitor
Moisturizes and Protects
Vitamin E + Niacinamide to nourish
Aloe to soothe
Zinc Oxide to promote healing
Unscented
No perfumes or dyes
100 ml / 3.4 fl oz
Meets TSA carry-on guidelines
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42853-102-13 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d262-f6ea-e053-dbdaa90aa703 | ALL-IN-ONE CREAM + MOISTURIZER |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOYL PEROXIDE | ACTIVE INGREDIENT | W9WZN9A0GM | 3 | |
| BENZOYL PEROXIDE | ACTIVE MOIETY | W9WZN9A0GM | 3 | |
| .ALPHA.-TOCOPHEROL ACETATE, D- | INACTIVE INGREDIENT | A7E6112E4N | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 3 | |
| ALKYL (C12-15) BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 3 | |
| ALOE | INACTIVE INGREDIENT | V5VD430YW9 | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 3 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 3 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 3 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 3 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 3 | |
| NIACINAMIDE | INACTIVE INGREDIENT | 25X51I8RD4 | 3 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 3 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | 3 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42853-102 | 42853-102-13 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOYL PEROXIDE | W9WZN9A0GM | ACTIB |
| ALKYL (C12-15) BENZOATE | A9EJ3J61HQ | IACT |
| ALOE | V5VD430YW9 | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| NIACINAMIDE | 25X51I8RD4 | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| .ALPHA.-TOCOPHEROL ACETATE, D- | A7E6112E4N | IACT |
| WATER | 059QF0KO0R | IACT |
| ZINC OXIDE | SOI2LOH54Z | 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 |
|---|---|---|---|---|---|---|
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / SUBCUTANEOUS | 225 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, COATED / ORAL | 1 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAMUSCULAR | 500 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | SOLUTION / TOPICAL | 7.22 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| DIAZOLIDINYL UREA | DIAZOLIDINYL UREA | H5RIZ3MPW4 | OINTMENT / TOPICAL | 0.1 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / AURICULAR (OTIC) | 0.9 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | GRANULE, FOR SOLUTION / ORAL | 14 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 40 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | OINTMENT / TOPICAL | 0.18 %w/w | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SUSPENSION/ DROPS / OPHTHALMIC | 0.1 %w/w | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRAVENOUS | 1620 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / PERINEURAL | 0.05 %w/v | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET / ORAL | 10 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | CREAM / VAGINAL | 0.81 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / INTRACARDIAC | 0.09 %w/v | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / TOPICAL | 2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, EXTENDED RELEASE / ORAL | 0.12 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION / INTRAMUSCULAR | 96 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / SUBCUTANEOUS | 43 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.15 %w/v | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | LOTION / TOPICAL | 4 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 0.8 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCUTANEOUS | 90 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | CONCENTRATE / ORAL | 2 mg/1ml | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / RECTAL | 0.01 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SUSPENSION / ORAL | 40 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v |
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 |
|---|---|---|---|---|---|---|
| 2c3257ea-c42e-43ec-b1ec-755e9dd7b6f3 | 3c36e034-472a-4081-8097-52f0900eb25a | 2012-03-06 | Warnings | 2c3257ea-c42e-43ec-b1ec-755e9dd7b6f3 3c36e034-472a-4081-8097-52f0900eb25a |
Adverse event summaries are temporarily unavailable. Other product information remains available.