Label: UNBLEMISH- benzoyl peroxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14222-2000-2 - Packager: Rodan & Fields, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 28, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use if you
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When using this product
- Skin irritation and dryness are 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 the product less frequently or in a lower combination.
- STOP USE
- Keep out of reach of children.
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Directions
- Cleanse skin thoroughly before applying this product.
- Dispense 1-2 pumps from each side. Blend product and apply evenly over the entire face, avoiding the eye area. Allow to penetrate skin. Do not rinse off.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily as needed or as directed by a doctor. If bothersome dryness or peeling occur reduce application to once a day or every other day and apply a moisturizer.
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develop, stop use of both products and ask a doctor.
- Other information
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Inactive ingredients
Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Biosaccharide Gum-1, Carbomer, C13-14 Isoparaffin, Ceramide AP, Ceramide EOP, Ceramide NP, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Disodium EDTA, Disodium Oleamido MEA Sulfosuccinate, Glycerin, Laureth-7, Niacinamide, Panthenol, Phytosphingosine, Polyacrylamide, Punica Granatum Extract, Purified Water, Sodium Lauroyl Lactylate, Xanthan Gum, Yucca Glauca Root Extract
- Principal Display Panel - Rodan+Fields
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INGREDIENTS AND APPEARANCE
UNBLEMISH
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14222-2000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) CARBOMER 934 (UNII: Z135WT9208) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CERAMIDE 6 II (UNII: F1X8L2B00J) CERAMIDE 1 (UNII: 5THT33P7X7) CERAMIDE 3 (UNII: 4370DF050B) CHAMOMILE (UNII: FGL3685T2X) CHOLESTEROL (UNII: 97C5T2UQ7J) EDETATE DISODIUM (UNII: 7FLD91C86K) DISODIUM OLEAMIDO MEA-SULFOSUCCINATE (UNII: 5M1101WGSY) GLYCERIN (UNII: PDC6A3C0OX) LAURETH-7 (UNII: Z95S6G8201) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) WATER (UNII: 059QF0KO0R) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) XANTHAN GUM (UNII: TTV12P4NEE) YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-2000-2 1 in 1 CARTON 1 22.5 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/01/2014 Labeler - Rodan & Fields, LLC (051659584) Establishment Name Address ID/FEI Business Operations Ei LLC 105803274 manufacture(14222-2000) , analysis(14222-2000) , label(14222-2000)
