SMART RELEASE BPO 5 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.

----------

SMART RELEASE BPO 5%

PURPOSE

TREATMENT OF ACNE

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

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.
  • 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.

DO NOT USE IF YOU HAVE VERY SENSITIVE SKIN OR SENSITIVE TO BENZOYL PEROXIDE.

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

OTHER INFORMATION

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

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 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.

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

QUESTIONS?

Call toll-free T 1-800-200-6365 or visit www.acneintellifillnce.com

01b LBL_SC_AI_Smart Release BPO 5pct

SMART RELEASE BPO  5 PERCENT
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73110-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73110-102-1130 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)

Revised: 6/2019
Document Id: 8d2f0715-6734-55a6-e053-2995a90ac63f
Set id: 8d2f3dfd-d821-dfc6-e053-2995a90a23f8
Version: 2
Effective Time: 20190629
 
SkinClinical AI, LLC