SLMD BP BODY WASH- benzoyl peroxide gel 
Owen Biosciences Inc.

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 Ingredients

Benzoyl Peroxide 5.0%

Use

For the management of acne.

Warnings
For external use only.

When using this product:
• skin irritation and dryness is more likely to
occur if you use another topical acne
medication at the same time. If irritation
occurs, only use one topical acne medication
at a time.
• avoid unnecessary sun exposure and use a
sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and dyed fabrics,
which may be bleached by this products
• skin irritation may occur, characterized by
redness, burning, itching, peeling, or possibly
swelling. Irritation may be reduced by using
the product less frequently or in a lower
concentration

Do not use if you

• have sensitive skin
• are sensitive to benzoyl peroxide

Stop use and ask a doctor if

•irriatation becomes servere

Keep out of reach of children.

If swallowed, get medical help or
contact a Poison Control Center
right away

Directions

• Lather between palms with water. Massage
in circular motion on wet skin for 20-30
seconds and rinse thoroughly.
• Because excessive drying of the 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.
• if going outside, apply sunscreen after using
this product. If irritation or sensitivity
develops, stop use of both products and ask
a doctor.
• Sensitivity Test for a New User: Apply
product sparingly to one or two small
affected areas during the first 3 days. If no
discomfort occurs, follow the directions
stated above.

Store in a cool, dry place.

Water, Sodium C14-16 Olefin Sulfonate,
Coco-Betaine, Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Cocoyl Arginine Amide,
Niacinamide, Mandelic Acid, Malic Acid,
Safflower Acids, Syringa Vulgaris (Lilac) Extract,
Penthenol, Aloe Barbadensis Leaf Extract,
Allantoin, Tocopheryl Acetate, Myristoyl
Tetrapeptide-13, Myristoyl Hexapeptide-23,
Lauric Acid, Lactobacillus Ferment Lysate,
Beta-glucan, Butylene Glycol, Eucalyptus
Globulus Leaf Oil, Pentylene Glycol,
Hydroxyphenyl Propamidobenzoic Acid,
Phenoxyethanol, Caprylyl Glycol.

For the treatment of Acne

BP Body Wash.jpg

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image description

SLMD BP BODY WASH 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-406
Route of AdministrationTopical
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 70 g  in 100 g
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) 15 g  in 100 g
COCO-BETAINE (UNII: 03DH2IZ3FY) 5 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-406-021 in 1 CARTON08/30/2019
1NDC:59958-406-01222 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/30/2019
Labeler - Owen Biosciences Inc. (790003045)
Registrant - Owen Biosciences Inc. (790003045)
Establishment
NameAddressID/FEIBusiness Operations
Owen Biosciences Inc.790003045manufacture(59958-406)

Revised: 8/2019
Document Id: 072e47b9-396e-4e7a-9d1b-10b6e6b4510a
Set id: 7a779c06-b75f-460a-9bb9-f07b2f2a442e
Version: 1
Effective Time: 20190830
 
Owen Biosciences Inc.