PERFECT ME SERUM- salicylic acid cream 
Lange SAS

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENTS
Salicyclic Acid (0.5%)
KEY INGREDIENTS
Azelaic Acid and Oleanolic Acid

PERFECT-ME SERUM
with Salicyclic Acid
Acne Treatment

Keep out of reach of children.

PERFECT-ME SERUM LANGE
INDICATIONS: For the Management of Acne
This non-oily and lightely scented treatment serum has been specially formulated for acne-prone skin. With a light, fresh texture, this pleasant will contribute to:
Help clear blackheads,
Help prevent the development of new acne pimples,
Allow skin to heal.

Not to be used for children under three years of age. Avoid contact with Eyes.
For external use only. If skin has allergic reaction, stop use immediately.

20 ml
0.68 FL. OZ

Label

WATER
PROPYLENE GLYCOL
POLYMETHYL METHACRYLATE
POTASSIUM AZELOYL DIGLYCINATE
GLYCERIN
CARBOMER
OLEANOLIC ACID
HYDROXYETHYL ACRYLATE/SODIUM
ACRYLOYLDIMETHYLTAURATE
COPOLYMER
SQUALANE
CHITOSAN SUCCINAMIDE
XANTHAN GUM
SALICYLIC ACID
BUTYLENE GLYCOL
PEG-60 ALMOND GLYCERIDES
CAPRYLYL GLYCOL
POLYSORBATE 60
SODIUM LACTATE
DISODIUM SUCCINATE
SODIUM CITRATE
CITRIC ACID
BIOTIN
BENZYL BENZOATE
HEXYL CINNAMAL
CITRONELLOL
ALPHA-ISOMETHYL IONONE
GERANIOL
EUGENOL
LIMONENE
LINALOOL
NORDIHYDROGUAIARETIC ACID
SODIUM METABISULFITE
CHLORPHENESIN
PHENOXYETHANOL
METHYLPARABEN
SODIUM METHYLPARABEN
BUTYLPARABEN
ETHYLPARABEN
PROPYLPARABEN
ISOBUTYLPARABEN
CI 77891 (TITANIUM DIOXIDE)
PERFECT ME SERUM 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51830-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 20 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
SQUALANE (UNII: GW89575KF9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BIOTIN (UNII: 6SO6U10H04)  
BENZYL BENZOATE (UNII: N863NB338G)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
GERANIOL (UNII: L837108USY)  
EUGENOL (UNII: 3T8H1794QW)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51830-052-0820 mg in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/18/2012
Labeler - Lange SAS (275956105)
Establishment
NameAddressID/FEIBusiness Operations
Lange SAS275956105manufacture(51830-052)

Revised: 2/2013
Document Id: ab4c5085-ea1a-446b-8c44-81d3599f84a7
Set id: ea0b4572-eeb3-4bff-bef9-ad843cd83d5a
Version: 2
Effective Time: 20130212
 
Lange SAS