OXY SENSITIVE SKIN ACNE CREAM CLEANSER- benzoyl peroxide 5% cream

Oxy Sensitive Skin Acne Cream Cleanser by

Drug Labeling and Warnings

Oxy Sensitive Skin Acne Cream 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 5%

Purpose

Benzoyl peroxide – Acne treatment

Uses

• for the treatment of acne
• clears acne pimples and allows skin to heal
• penetrates pores to control blackheads and whiteheads
• helps prevent new acne pimples from forming

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 the 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 massage gently into face. If desired, leave on for 1-2 minutes.
• rinse thoroughly and pat dry
• follow with a non-comedogenic moisturizer if needed
• because excessive 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 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.

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, chlorphenesin, citric acid, glycerin, hydrolyzed soy protein, PEG-8 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

Questions?

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

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INGREDIENTS AND APPEARANCE

OXY SENSITIVE SKIN ACNE CREAM CLEANSER 
benzoyl peroxide 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-1004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
XANTHAN GUM (UNII: TTV12P4NEE)
RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PORTULACA OLERACEA LEAF (UNII: 9JW9D9JGHZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-1004-1	148 mL in 1 TUBE; Type 0: Not a Combination Product	08/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/15/2024

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	manufacture(10742-1004)