SLMD BP BODY WASH- benzoyl peroxide gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Benzoyl Peroxide 5.0%
Available from:
Owen Biosciences Inc.
Administration route:
Topical
Prescription type:
OTC DRUG
Therapeutic indications:
For the management of acne. 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 • have sensitive skin • are sensitive to benzoyl peroxide •irriatation becomes servere For the treatment of Acne
Authorization status:
OTC monograph final
Authorization number:
59958-406-01, 59958-406-02

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%

Us e

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

BP Body Wash.jpg

SLMD BP BODY WASH

benzoyl peroxide gel

Product Information

Owen Biosciences Inc.

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 9 58 -40 6

Route of Administration

To pic a l

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO YL PERO XIDE (UNII: W9 WZN9 A0 GM) (BENZOYL PEROXIDE - UNII:W9 WZN9 A0 GM)

BENZOYL PEROXIDE 5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

70 g in 10 0 g

SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U)

15 g in 10 0 g

CO CO -BETAINE (UNII: 0 3DH2IZ3FY)

5 g in 10 0 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 9 58 -40 6 -0 2

1 in 1 CARTON

0 8 /30 /20 19

1

NDC:59 9 58 -40 6 -0 1

222 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

0 8 /30 /20 19

Labeler -

Owen Biosciences Inc. (790003045)

Registrant -

Owen Biosciences Inc. (790003045)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Owen Bio sciences Inc.

79 0 0 0 30 45

ma nufa c ture (59 9 58 -40 6 )

Revised: 8/2019

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