SALICYLIC SERUM 1 PERCENT- salicylic acid gel

SALICYLIC SERUM by

Drug Labeling and Warnings

SALICYLIC SERUM by is a Otc medication manufactured, distributed, or labeled by SkinClinical AI, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SALICYLIC ACID 1%

PURPOSE

TREATMENT OF ACNE

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.

OTHER INFORMATION

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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 affected area with a thin layer 1 to 3 times per day. Due to 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 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), SD Alcohol 40-B, Butylene Glycol, Ethoxydiglycol, Hamamelis Virginiana (Witch Hazel) Water, Saccharide lsomerate, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycolic Acid, Lactic Acid, Hydroxyethylcellulose, Potassium Hydroxide, Magnesium Aluminum Silicate, Citric Acid, Xanthan Gum, Fragrance (Parfum)

QUESTIONS?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SALICYLIC SERUM  1 PERCENT
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73110-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
ZINC SULFATE (UNII: 89DS0H96TB)
LACTIC ACID (UNII: 33X04XA5AT)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCOLIC ACID (UNII: 0WT12SX38S)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
WITCH HAZEL (UNII: 101I4J0U34)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73110-101-11	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/10/2019

Labeler - SkinClinical AI, LLC (116981342)

Registrant - SkinClinical AI, LLC (116981342)