Label: UNBLEMISH DUAL INTENSIVE ACNE TREATMENT- benzoyl peroxide lotion
- NDC Code(s): 14222-2120-1
- Packager: Rodan & Fields
- 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 December 29, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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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, only use one topical acne medication at a time.
When using this product
- 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.
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Directions
- Clean the skin thoroughly before applying this product. Dispense 1-2 pumps from each side. Blend product evenly. Cover the entire affected area with a thin even layer one to three times daily. Do not rinse product off face.
- 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.
- Wash hands after application to help avoid staining fabrics.
- Other Information
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Inactive Ingredients
Water, Ethoxydiglycol, Glycerin, Polyacrylamide, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Allantoin, Niacinamide, Panthenol, Punica Granatum Fruit Extract, Yucca Glauca Root Extract, Ceramide AP, Ceramide EOP, Ceramide NP, Fragrance (Parfum), Biosaccharide Gum-1, Disodium Cocamido MIPA-Sulfosuccinate, Carbomer, Cholesterol, Leuconostoc/Radish Root Ferment Filtrate, Corn Starch Modified, Phytosphingosine, Sodium Lauroyl Lactylate, Xanthan Gum, Laureth-7, Aminomethyl Propanol, Disodium Oleamido MEA-Sulfosuccinate, Cl3-14 lsoparaffin, PEG-7 Glyceryl Cocoate, BHT, Disodium EDTA, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool
- Questions
- Principal Display Panel - 45mL / 1.5 Fl. Oz. Carton Label
- Principal Display Panel - 45mL / 1.5 Fl. Oz. Tube Label
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INGREDIENTS AND APPEARANCE
UNBLEMISH DUAL INTENSIVE ACNE TREATMENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14222-2120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 0.025 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) GLYCERIN (UNII: PDC6A3C0OX) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) BENZYL ALCOHOL (UNII: LKG8494WBH) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CERAMIDE 1 (UNII: 5THT33P7X7) CERAMIDE AP (UNII: F1X8L2B00J) CERAMIDE NP (UNII: 4370DF050B) CHOLESTEROL (UNII: 97C5T2UQ7J) DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GERANIOL (UNII: L837108USY) LAURETH-7 (UNII: Z95S6G8201) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) POMEGRANATE (UNII: 56687D1Z4D) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) STARCH, CORN (UNII: O8232NY3SJ) XANTHAN GUM (UNII: TTV12P4NEE) YUCCA GLAUCA ROOT (UNII: 1A15YBH7N1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14222-2120-1 1 in 1 CARTON 02/13/2019 1 45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/13/2019 Labeler - Rodan & Fields (051659584)
