ALL-IN-ONE  - benzoyl peroxide lotion 
AUGUSTUS BIOMED LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient
Benzoyl Peroxide 5%

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
All-in-One label C rev 020712


ALL-IN-ONE 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42853-101
Route of AdministrationTRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE 
ALOE 
BENZYL ALCOHOL 
BUTYLPARABEN 
DIAZOLIDINYL UREA 
ALCOHOL 
ETHYLPARABEN 
LACTIC ACID 
METHYLPARABEN 
NIACINAMIDE 
PHENOXYETHANOL 
PROPYLPARABEN 
SODIUM METABISULFITE 
SORBIC ACID 
.ALPHA.-TOCOPHEROL ACETATE, D- 
WATER 
ZINC OXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:42853-101-13100 mL in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/25/2012

Labeler - AUGUSTUS BIOMED LLC (017854586)
Registrant - AUGUSTUS BIOMED LLC (017854586)

Revised: 02/2012 AUGUSTUS BIOMED LLC