SKINCEUTICALS SILYMARIN CF ACNE TREATMENT- salicylic acid solution

SkinCeuticals Silymarin CF Acne Treatment by

Drug Labeling and Warnings

SkinCeuticals Silymarin CF Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 0.5%

Purpose

Acne treatment

Uses

- for the treatment of acne

- reduces the number and severity of acne blemishes and allows skin to heal

Warnings

For external use only

Flammable until dry.

Keep away from flames and heat.

When using this product

skin irritation and dryness is more liekly 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.

Keep out of reach of children.

If 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 in a cool, dark place

Inactive ingredients

water, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

Questions or comments?

Call 1-800-811-1660 Monday - Friday (9 a.m. - 5 p.m. CST)

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INGREDIENTS AND APPEARANCE

SKINCEUTICALS SILYMARIN CF ACNE TREATMENT 
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LAURETH-23 (UNII: N72LMW566G)
MILK THISTLE (UNII: U946SH95EE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FERULIC ACID (UNII: AVM951ZWST)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-068-01	1 in 1 CARTON	01/01/2021
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-068-02	1 in 1 CARTON	01/01/2021
2		55 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 49967-068-03	1 in 1 CARTON	01/01/2021
3		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 49967-068-04	10 in 1 CARTON	01/01/2021
4		4 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/31/2020

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		032565959	manufacture(49967-068)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-068)

Establishment
Name	Address	ID/FEI	Business Operations
Interspray		364829903	pack(49967-068)