SMART RELEASE BPO 10 PERCENT- benzoyl peroxide lotion 
SkinClinical AI, LLC

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.

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SMART RELEASE BPO 10%

Active ingredients

BENZOYL PEROXIDE 10%

PURPOSE

TREATMENT OF ACNE

USE

For the treatment of acne.

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.

Do not use if you have very sensitive skin or sensitive to benzoyl peroxide.

Other information

Keep tightly closed.
Protect from excessive heat (40° / 140° F) and protect from freezing

Stop use and ask a doctor if irritation or sensitivity develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Important to use on a clean face. Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day 1 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.

INACTIVE INGREDIENTS

Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sulfur, 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 (Bergamo!} Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Tangerina (Tangerine) Peel Oil

QUESTIONS?

CALL TOLL-FREE T 1-800-200-6365 OR VISIT WWW.ACNEINTELLIGENCE.COM

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SMART RELEASE BPO  10 PERCENT
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73110-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
SULFUR (UNII: 70FD1KFU70)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73110-105-1130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/16/2019
Labeler - SkinClinical AI, LLC (116981342)
Registrant - SkinClinical AI, LLC (116981342)

Revised: 9/2019
Document Id: 91eac465-de08-4e90-e053-2a95a90a99e3
Set id: 8d2f3dfd-d83e-dfc6-e053-2995a90a23f8
Version: 4
Effective Time: 20190906
 
SkinClinical AI, LLC