Label: LET ME BE PERFECTLY CLEAR- benzoyl peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 42485-003-01, 42485-004-01 - Packager: Biopelle, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 11, 2011
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only.
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.
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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
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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
- Inactive Ingredients
- Questions?
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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
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INGREDIENTS AND APPEARANCE
LET ME BE PERFECTLY CLEAR
benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42485-004 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42485-004-01 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 45 g Part 1 of 1 OC EIGHT
benzoyl peroxide gelProduct Information Item Code (Source) NDC:42485-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 7 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42485-003-01 45 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 04/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 04/01/2011 Labeler - Biopelle, Inc. (808158823) Establishment Name Address ID/FEI Business Operations Ferndale Laboratories, Inc. 005320536 manufacture