Oxy Maximum Action Spot Treatment description, usages, side effects, indications, overdosage, supplying and lots more!

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Oxy Maximum Action Spot Treatment

The Mentholatum Company

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne treatment

Oxy Maximum Action Spot Treatment Uses

treats and helps prevent acne

Warnings

For external use only

Do Not Use

  • •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

  • •clean skin thoroughly before applying this product
  • •cover entire affected area with a thin layer 1 to 3 times daily
  • •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.

Inactive Ingredients

anhydrous citric acid, butylene glycol, carbomer homopolymer, diazolidinyl urea, dimethicone, dimethyl isosorbide, edetate disodium, fragrance, glycerin, hydrolyzed soy protein, iodopropynyl butylcarbamate, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, portulaca oleracea extract, propylene glycol, purified water, silica, sodium citrate, sodium hydroxide, xanthan gum

Package/Label Principal Display Panel

Oxy Maximum Action Spot Treatment

benzoyl peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10742-8301
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 100 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
BUTYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
DIAZOLIDINYL UREA
DIMETHICONE
DIMETHYL ISOSORBIDE
EDETATE DISODIUM
GLYCERIN
SOY PROTEIN
IODOPROPYNYL BUTYLCARBAMATE
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
PEG/PPG-4/12 DIMETHICONE
PURSLANE
propylene glycol
water
SILICON DIOXIDE
SODIUM CITRATE
SODIUM HYDROXIDE
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 18.4 in 1 TUBE
2 NDC:10742-8301-2 4 in 1 POUCH

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2013-01-15


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