OXY Advanced Care Soothing Cream Acne Cleanser: Package Insert and Label Information

OXY ADVANCED CARE SOOTHING CREAM ACNE CLEANSER- benzoyl peroxide gel
The Mentholatum Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Benzoyl peroxide 10%

Purpose

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 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 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 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, fragrance, glycerin, hydrolyzed soy protein, hydroxyphenyl propamidobenzoic acid, PEG-8 dimethicone, pentylene glycol, phenoxyethanol, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

Questions?

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

Package/Label Principal Display Panel

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OXY ADVANCED CARE SOOTHING CREAM ACNE CLEANSER
benzoyl peroxide gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-1202
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CETOSTEARYL ALCOHOL
SODIUM C14-16 OLEFIN SULFONATE
DISODIUM LAURETH SULFOSUCCINATE
CAPRYL/CAPRAMIDOPROPYL BETAINE
XANTHAN GUM
BUTYLENE GLYCOL
CHLORPHENESIN
ANHYDROUS CITRIC ACID
GLYCERIN
SOY PROTEIN
HYDROXYPHENYL PROPAMIDOBENZOIC ACID
PEG-8 DIMETHICONE
PENTYLENE GLYCOL
PHENOXYETHANOL
PROPANEDIOL
RHODOMYRTUS TOMENTOSA FRUIT
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM HYDROXIDE
SODIUM LAUROYL SARCOSINATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10742-1202-1 148 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 09/01/2021
Labeler — The Mentholatum Company (002105757)

Revised: 09/2021 The Mentholatum Company

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