Label: SMART RELEASE BPO 5 PERCENT- benzoyl peroxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73110-102-11 - Packager: SkinClinical AI, 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 June 29, 2019
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- PURPOSE
- ACTIVE INGREDIENT
- 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, ONLY USE 1 TOPICAL ACNE MEDICATION AT A TIME.
- AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN. AVOID CONTACT WITH THE EYES, LIPS AND MOUTH. SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHINH, PEELING, OR POSSIBLY SWELLING.
- IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.
- OTHER INFORMATION
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
IMPORTANT TO USE ON A CLEAN FACE. COVER THE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES PER DAY. BECAUSE OF EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION PER DAY THEN GRADUALLY INCREASE TO TWO APPLICATIONS PER DAY, ONE MORNING AND ONE EVENING IF NEEDED, OR AS DIRECTED BY A DOCTOR. IF DRYNESS OR PEELING OCCURS, REDUCE USE TO ONCE A DAY OR ONCE EVERY OTHER DAY. IF GOING OUTSIDE, USE A SUNSCREEN. IF IRRITATION OR SENSITIVITY DEVELOPS STOP USING BOTH PRODUCTS AND ASK A DOCTOR.
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INACTIVE INGREDIENTS
Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-8 SMDI Copolymer, Lactobacillus Ferment, Glycolic Acid, Lactic Acid, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Potassium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Hydrolyzed Algin, Zinc Sulfate, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil.Citrus Tangerina (Tangerine) Peel Oil
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INGREDIENTS AND APPEARANCE
SMART RELEASE BPO 5 PERCENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73110-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) GLYCOLIC ACID (UNII: 0WT12SX38S) LACTIC ACID (UNII: 33X04XA5AT) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM ALGINATE (UNII: C269C4G2ZQ) ZINC SULFATE (UNII: 89DS0H96TB) EDETATE DISODIUM (UNII: 7FLD91C86K) BERGAMOT OIL (UNII: 39W1PKE3JI) GRAPEFRUIT OIL (UNII: YR377U58W9) ORANGE OIL (UNII: AKN3KSD11B) TANGERINE PEEL (UNII: JU3D414057) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73110-102-11 30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 02/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/16/2019 Labeler - SkinClinical AI, LLC (116981342)
