ACNE SPOT REPAIR- benzoyl peroxide lotion

ACNE SPOT REPAIR by

Drug Labeling and Warnings

ACNE SPOT REPAIR 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 10%

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 are 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:

• Clean the skin before applying 
• Cover only acne spot  with a thin layer 1 to 3 times daily
• Because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
• If dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, allow product to dry, then use a sunscreen 
• Store at 20-25°C (68-77°F)

Inactive Ingredients

Aqua purificata, c12-15 alkyl benzoate, urea, butylene glycol, cyclopentasiloxane, magnesium aluminum silicate, steareth-20, peg-100 stearate, zea mays, hydroxyethyl acrylate/sodium acryloyldimethyl, taurate copolymer, squalane, polysorbate 60, chamomilla recutita extract, camellia oleifera leaf extract, phospholipids, retinyl palmitate, tocopherol, ascorbyl palmitate, beta-carotene, ethylhexylglycerin, cetearyl alcohol, glycerin, caprylyl glycol, dimethicone, acrylates/c10-30 alkly acrylate crosspolymer, steareth-2, butylene glycol, propylene glycol, panthenol, disodium EDTA, allantoin, phytonadione.

Package Labeling:

INGREDIENTS AND APPEARANCE

ACNE SPOT REPAIR 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71397-821
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 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: 71397-821-75	21 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)