OXY 10 ACNE CLEANSER- benzoyl peroxide cream

Oxy 10 Acne Cleanser by

Drug Labeling and Warnings

Oxy 10 Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

Uses

treats and helps prevent acne

Warnings

For external use only

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

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 product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.

Stop use and ask a doctor if

irritation becomes severe

If pregnant or breast-feeding

ask a health professional before use.

Keep Out of Reach of Children

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

Directions

• wet face
• apply to hands then work into a lather and massage gently onto face
• rinse thoroughly and pat dry
• because excessive drying of the skin may occur, start with 1 use daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce usage 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: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.

Other information

• THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
• KEEP TIGHTLY CLOSED
• avoid storing at temperatures above 100°F (38°C)

Inactive ingredients

water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, citric acid, diazolidinyl urea, fragrance, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, methylparaben, PEG-8 dimethicone, pentylene glycol, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

Questions?

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

OXY 10 ACNE CLEANSER 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-1397
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SOY PROTEIN (UNII: R44IWB3RN5)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-1397-1	148 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2018
2	NDC: 10742-1397-2	185 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2018

Labeler - The Mentholatum Company (002105757)