ALL-IN-ONE- benzoyl peroxide cream

ALL-IN-ONE by

Drug Labeling and Warnings

ALL-IN-ONE by is a Otc medication manufactured, distributed, or labeled by AUGUSTUS BIOMED LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Benzoyl Peroxide 5% w/v

PURPOSE

Purpose

Acne treatment

INDICATIONS & USAGE

Use for the treatment of acne

WARNINGS

Warnings - For external use only

DO NOT USE

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

Stop use and consult a doctor if irritation becomes severe.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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 SAFETY INFORMATION

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.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

ALL-IN-ONE 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42853-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALOE (UNII: V5VD430YW9)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ALCOHOL (UNII: 3K9958V90M)
ETHYLPARABEN (UNII: 14255EXE39)
LACTIC ACID (UNII: 33X04XA5AT)
METHYLPARABEN (UNII: A2I8C7HI9T)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SORBIC ACID (UNII: X045WJ989B)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42853-102-13	100 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/25/2012

Labeler - AUGUSTUS BIOMED LLC (017854586)

Registrant - AUGUSTUS BIOMED LLC (017854586)