Label: SLMD BP BODY WASH- benzoyl peroxide gel
Contains inactivated NDC Code(s)
NDC Code(s): 59958-406-01, 59958-406-02
- Packager: Owen Biosciences Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 30, 2019
If you are a consumer or patient please visit this version.
- Active Ingredients
WarningsFor 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
• 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
- Do not use if you
- Stop use and ask a doctor if
- Keep out of reach of children.
• 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
• if going outside, apply sunscreen after using
this product. If irritation or sensitivity
develops, stop use of both products and ask
• 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
- OTHER SAFETY INFORMATION
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.
- BP Body Wash.jpg
INGREDIENTS AND APPEARANCE
SLMD BP BODY WASH
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59958-406 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 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:59958-406-02 1 in 1 CARTON 08/30/2019 1 NDC:59958-406-01 222 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/30/2019 Labeler - Owen Biosciences Inc. (790003045) Registrant - Owen Biosciences Inc. (790003045) Establishment Name Address ID/FEI Business Operations Owen Biosciences Inc. 790003045 manufacture(59958-406)