ACNE OIL CONTROL PRIMER- salicylic acid liquid 
Allure Labs

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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Drug Facts

Active Ingredients

Salicylic Acid 2 %


Purpose
Acne Treatment

Uses
For the treatment of acne


Warnings

For external use only

Do not use

If irritation occurs


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 one
topical acne medication
at a time.


If bothersome dryness or
peeling occurs,


Keep out of reach of children


If product is swallowed,
get medical help or
contact a Poison Control
Center right away.

Directions
Clean the skin thoroughly
before applying this
product
Cover the entire affected
area with a thin layer one
to three times daily
Because excessive drying
of the skin may occur, start
with one application daily,
then gradually increase to
two or three times daily if
needed or as directed by
a doctor
If bothersome dryness or
peeling occurs, reduce
application to once a day
or every other day


Other Information


Store at 20°- 25°C (68° - 77°F)


Inactive Ingredients
Water (Aqua), Dimethicone,
Butylene Glycol, Dimethicone
Crosspolymer, Ammonium
Polyacryloyldimethyl Taurate,
Hydroxyethylcellulose,
Serenoa Serrulata (Saw
Palmetto) Fruit Extract,
Sodium Ascorbyl Phosphate,
Niacinamide, Linoleic Acid,
Linolenic Acid,
Docosahexaenoic Acid,
Eicosapentaenoic Acid,
Nigella Sativa (Black Cumin)
Seed Oil, Scutellaria
Baicalensis Root Extract, Zinc
Gluconate, Glycerin,
Tocopherol, Oleanolic Acid,
Enantia Chlorantha Bark
Extract, Caprylyl Glycol,
Ethylhexylglycerin, Hexylene
Glycol, Disodium Phosphate,
Phenoxyethanol, Polysorbate
60, Sodium Hydroxide,
Sodium Phosphate.

Acne & Oil control Primer

ACNE OIL CONTROL PRIMER 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
SAW PALMETTO (UNII: J7WWH9M8QS)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DOCONEXENT (UNII: ZAD9OKH9JC)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
LINOLENIC ACID (UNII: 0RBV727H71)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ICOSAPENT (UNII: AAN7QOV9EA)  
GLYCERIN (UNII: PDC6A3C0OX)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4211-21 in 1 CARTON04/01/2022
1NDC:62742-4211-145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/01/2022
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4211)

Revised: 4/2022
Document Id: db9b5de2-c07d-0b21-e053-2995a90ae9a9
Set id: db9b5de2-c07c-0b21-e053-2995a90ae9a9
Version: 1
Effective Time: 20220401
 
Allure Labs