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  5. Label Information: Oxy Total Care Clarifying Moisturizer

FDA Label for Oxy Total Care Clarifying Moisturizer

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS

Oxy Total Care Clarifying Moisturizer Product Label

The following document was submitted to the FDA by the labeler of this product The Mentholatum Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Benzoyl peroxide 2.5%


Purpose



Benzoyl peroxide – Acne treatment


Keep Out Of Reach Of Children



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


Uses



  • •For the treatment of acne.
  • •Helps prevent new acne blemishes.

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, use only 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.


Directions



  • •clean the skin thoroughly before applying this product
  • •use a dime-sized amount to cover the entire affected area with a thin layer one to two times daily
  • •because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
  • •Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated 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, glycerin, butylene glycol, carbomer, chlorphenesin, citric acid, dimethyl isosorbide, disodium EDTA, hyaluronic acid, hydrolyzed algin, lauryl methacrylate/glycol dimethacrylate crosspolymer, PEG/PPG-4/12 dimethicone, phenoxyethanol, phytic acid, portulaca oleracea extract, silanetriol, sodium citrate, sodium hydroxide, xanthan gum, zinc sulfate

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