BENZOYL PEROXIDE ACNE- acne lotion lotion

Benzoyl Peroxide Acne by

Drug Labeling and Warnings

Benzoyl Peroxide Acne by is a Otc medication manufactured, distributed, or labeled by Skin PS Brands, Owen Biosciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

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 eyes, lips and mouth.
• Avoid contact with hair and dyed fabrics, which may be bleached by this product.
• 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 very sensitive skin, and are sensitive to Benzyl Peroxide.

Stop use and ask a doctor if

skin irritation becomes severe.

Keep out of reach of children.

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

Directions

• Apply a thin layer in the morning to clean, dry skin.
• If bothersome irritation, drying and or peeling occurs, start with one application daily or every other day, then gradually increase to two times daily.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

• Store in a cool, dry place.

Inactive Ingredients

Water, Behenoxy Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Glyceryl Stearate SE, Lysozyme HCl, Cocoyl Arginine Amide, Polyacrylamide, Capryloyl Glycine, Phenoxyethanol, Caprylyl Glycol, Glyceryl Stearate, C13-14 Isoparaffin, Laureth-7, Tocopheryl Acetate, Decylene Glycol, Butylene Glycol, Propanediol, Mirabilis Jalapa Extract, Sodium Carboxymethyl Betaglucan, Aloe Barbadensis Leaf Juice, Polyglyceryl-10 Laurate, Cocoglycerides, Maltodextrin, Syringa Vulgaris (Lilac) Extract, Beta-Glucan, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Myristoyl Tetrapeptide-13, Tromethamine.

Questions or comments?

Questions or comments?

www.slmdskincare.com

Distributed by Skin PS Brands

Los Angeles, CA 90066

Made in the USA with globally sourced materials.

SLMD Sandra Lee MD

Created by Dr. Pimple Popper

Benzoyl Peroxide

Acne Lotion

Acne Treatment

Eliminates acne-causing bacteria

while treating active acne breakouts.

1.5 fl. oz. - 44 mL

SANDRA LEE MD

@SLMDSKINCARE

Unit Carton:

Primary:

Real results for everybody.

AM

Directions: After cleansing, apply a thin layer to clean, dry skin using gentle, upward strokes. For best results, use in the morning as part of the SLMD Acne System or up to two times daily.

TARGETS

RED, INFLAMMATORY &

NON-INFLAMMATORY ACNE

ACNE-CAUSING BACTERIA

Questions or comments?

www.slmdskincare.com

Distributed by Skin PS Brands

Los Angeles, CA 90066

Made in the USA with globally sourced materials.

INGREDIENTS AND APPEARANCE

BENZOYL PEROXIDE ACNE 
acne lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73318-7006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
MIRABILIS JALAPA WHOLE (UNII: 0F7H3SM0G0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ARGININE (UNII: 94ZLA3W45F)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SYRINGA VULGARIS WHOLE (UNII: U49SHU1VCI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
LYSOZYME HYDROCHLORIDE (UNII: 4YRW73H69V)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 CARBOXYLIC ACID (UNII: 3180MRU2VG)
DECYLENE GLYCOL (UNII: S57M60MI88)
MYRISTOYL TETRAPEPTIDE-4 (UNII: 87AV1IB2EU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
TROMETHAMINE (UNII: 023C2WHX2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73318-7006-1	1 in 1 CARTON	07/01/2023
1		44 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/01/2023

Labeler - Skin PS Brands (081085221)

Registrant - Skin PS Brands (081085221)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences		790003045	manufacture(73318-7006)