SMART RELEASE MANDELIC 8 PERCENT- salicylic acid gel 
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 Mandelic 8%

ACTIVE INGREDIENT

SALICYLIC ACID  .5%

PURPOSE

TREATMENT OF ACNE

USE

FOR THE TREATMENT OF ACNE

WARNINGS

For External Use Only.

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.

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 Poisorl fontrol Center right away. This product contains Mandelic Acid that may increase. Your skin's sensitivity to the sun and the possibility of sunburn. Use a sunscreen, wear protective clothing and limit exposure to the sun using this product and for one week after you stop. Store at room temperature.

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, one morning and one evening ff 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 (Agua), SD Alcohol 40-B, Mandelic Acid, Butylene Glycol,Hamamelis Virginiana (Witch Hazel) Leaf Water, Lactobacillus Ferment, PEG-8 SMDI Copolymer, Niacinamide, Lactic Acid, Sodium PCA, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycerin, Opuntia Ficus lndica (Nopal Cactus), Saccharomyces Cerevisiae (Yeast) Extract, Hydroxyethylcellulose, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oi!, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Tangerina (Tangerine) Peel Oil

01b LBL_SC_AI_Smart Release Mandelic 8pct

SMART RELEASE MANDELIC  8 PERCENT
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73110-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
MANDELIC ACID (UNII: NH496X0UJX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WITCH HAZEL (UNII: 101I4J0U34)  
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6)  
NIACINAMIDE (UNII: 25X51I8RD4)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
ZINC SULFATE (UNII: 89DS0H96TB)  
GLYCERIN (UNII: PDC6A3C0OX)  
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
BILBERRY (UNII: 9P2U39H18W)  
SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB)  
ORANGE (UNII: 5EVU04N5QU)  
LEMON (UNII: 24RS0A988O)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
ORANGE OIL (UNII: AKN3KSD11B)  
MANDARIN OIL (UNII: NJO720F72R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73110-103-1130 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: 6/2019
Document Id: 8d2f82c1-47e0-7791-e053-2a95a90af015
Set id: 8d2fa61a-033b-625d-e053-2a95a90aa0c6
Version: 3
Effective Time: 20190629
 
SkinClinical AI, LLC