Label: RODAN AND FIELDS UNBLEMISH - ACNE MEDICATED- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 56152-0010-1, 56152-0010-2 - Packager: Cosmetic Enterprises
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 23, 2010
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ACTIVE INGREDIENT
Active Ingredients
Benzoyl Peroxide 2.5%
Warnings: For external use only. When using this product avoid unnecessary sun exposure and use sunscreen. If going outside, use a sunscreen; allow UNBLEMISH 4 TREAT to dry, then follow directions in the sunscreen labeling. If irritation or sensitivity develops, discontinue use of both products and consult a doctor. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not get into eyes. If excessive skin irritation develops or increase, discontinue use and consult a doctor.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RODAN AND FIELDS UNBLEMISH - ACNE MEDICATED
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-0010-2 1 in 1 BOX 1 NDC:56152-0010-1 30 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 01/01/2009 Labeler - Cosmetic Enterprises (017701475) Registrant - Rodan & Fields, LLC. (051659584) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises 017701475 manufacture