SKINCEUTICALS SILYMARIN CF ACNE TREATMENT- salicylic acid solution 
L'Oreal USA Products Inc

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Drug Facts

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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SKINCEUTICALS SILYMARIN CF ACNE TREATMENT 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-068-011 in 1 CARTON01/01/2021
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-068-021 in 1 CARTON01/01/2021
255 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49967-068-031 in 1 CARTON01/01/2021
315 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:49967-068-0410 in 1 CARTON01/01/2021
44 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00612/31/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence, LLC032565959manufacture(49967-068)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(49967-068)
Establishment
NameAddressID/FEIBusiness Operations
Interspray364829903pack(49967-068)

Revised: 12/2023
Document Id: 2b72a13a-b70e-4947-8705-c64d4d0d47f8
Set id: aa439d77-7ba5-4699-8e8b-3bba35f5094d
Version: 4
Effective Time: 20231211
 
L'Oreal USA Products Inc