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  5. Label Information: Let Me Be Perfectly Clear

FDA Label for Let Me Be Perfectly Clear

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE IF YOU
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE LABEL

Let Me Be Perfectly Clear Product Label

The following document was submitted to the FDA by the labeler of this product Biopelle, Inc.. 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 7%


Purpose



Acne Treatment


Use



for the treatment of 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, 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 possible 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

Keep Out Of Reach Of Children.



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


Directions



  • cleanse the skin thoroughly before applying
  • cover the entire affected area with a thin layer 1 to 3 times a day
  • because excessive drying of th 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 a sunscreen after using this product.  Allow OC Eight Acne Mattifying Gel to dry, then follow directions in the sunscreen labeling.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information



Store at controlled room temperature 59° - 86° F (15° - 30° C).


Inactive Ingredients



water, DVB/isobornyl methacrylate/lauryl methacrylate copolymer, propylene glycol, PEG-400, carbomer 940, sodium hydroxide, disodium EDTA


Questions?



1-866-424-6735 weekdays


Package Label



LET ME BE PERFECTLY CLEAR Acne Treatment Kit NDC 42485-004-01

AFA Cream Cleanser with Dead Sea Minerals 8 fl oz / 236 mL

PRESCRIBEDsolutions Line Subtractor 27 mL / .9 fl oz

OC Eight® Acne Mattifying Gel 1.6 oz / 45 g

Marketed by Biopelle, Inc.
A Ferndale Pharma Group company
Ferndale, Michigan 48220
www.biopelle.com

LetMeBePerfectlyClearCartonFront - LetMeBePerfectlyClearCartonFront

LetMeBePerfectlyClearCartonFront - LetMeBePerfectlyClearCartonFront



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