ACNE OIL CONTROL PRIMER- salicylic acid liquid

Acne Oil Control Primer by

Drug Labeling and Warnings

Acne Oil Control Primer by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Salicylic Acid 2 %

PURPOSE

Purpose
Acne Treatment

INDICATIONS & USAGE

Uses
For the treatment of acne

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

If irritation occurs

WHEN USING

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.

STOP USE

If bothersome dryness or
peeling occurs,

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other Information

Store at 20°- 25°C (68° - 77°F)

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE OIL CONTROL PRIMER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4211-2	1 in 1 CARTON	04/01/2022
1	NDC: 62742-4211-1	45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/01/2022

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4211)