ACNE THERAPY- benzoyl peroxide lotion

ACNE THERAPY by

Drug Labeling and Warnings

ACNE THERAPY by is a Otc medication manufactured, distributed, or labeled by menScience Androceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

​Active Ingredient

Benzoyl Peroxide 3%

​Purpose

Acne Treatment

​Uses

for the treatment and prevention of acne

​Warnings

​For external use only.

Do not use:

If you have very sensitive skin or sensitive to benzoyl peroxide.

​When using this product:

Apply to affected areas only.  Avoid unnecessary sun exposure and use a sunscreen.  Do not use in or near the eyes, lips or mouth.  This product may bleach hair or dyed fabrics.  Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin.

Discontinue use and ask a doctor

 if skin irritation becomes severe or if you are using more than one acne medication.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

​Directions:

Shake before using.  Apply to clean skin.  Cover the affected area with a thin layer 1 to 3 times daily.  Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.  If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day.  If going outside, allow product to dry, then use a sunscreen.  Store at 20-25 ​o​C (68-77 ​o​F)

​Inactive Ingredients

Aqua purificata (purified water), C12-15 Alkyl Benzoate, Urea, Butylene Glycol, Cyclopentasiloxane, Magnesium aluminum silicated, Steareth-20, Peg-100 stearate, Zea mays (corn) starch, Hydroxyethyl acrylate/sodium acryloydimethyl, Taurate copolymer, Squalane, Polysorbate 60, Chamomilla recutita (matricaria) extract, Camellia oleifera leaf extract, Phospholipids, Retinyl palmitate, Tocopherol, Ascorbyl palmitate, Beta-carotene, Ethylhexylglycerin, Cetearyl alcohol, Glycerin, Caprylyl glycol, Dimethicone, Acrylates/C10-30 alkyl acrylate crosspolymer, Steareth-2, Butylene Glycol, Propylene glycol, Panthenol, Disodium EDTA, Allantoin, Phytonadione.

Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE THERAPY 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71397-822
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
UREA (UNII: 8W8T17847W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
STEARETH-20 (UNII: L0Q8IK9E08)
PEG-100 STEARATE (UNII: YD01N1999R)
STARCH, CORN (UNII: O8232NY3SJ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARETH-2 (UNII: V56DFE46J5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALLANTOIN (UNII: 344S277G0Z)
PHYTONADIONE (UNII: A034SE7857)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71397-822-55	45 g in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/20/2017

Labeler - menScience Androceuticals, LLC (017390110)