NUVILEO ACNE FACE WASH- salicylic acid solution, gel forming / drops 
Cosmetic Specialty Labs, Inc.

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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Nuviléo™ Acne Face Wash

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

for treatment of acne

Warnings

for external use only

Ask a doctor if you are using other topical acne medications at the same time or immediately following use of this product. If increased dryness or irritation occurs, only one medication should be used, unless directed by a doctor.

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Use twice a day. Wet face, apply to hands, add water and work into a lather. Massage into your face, rinse.

Inactive ingredients

Aloe Barbadensis Mill, Caprylyl Glycol, Cocamidopropyl Betaine, Coco-Glucoside, Fragrance, Glyceryl Oleate, Hydrastis canadensis L., Lauramide D A, Lauryl Gucoside, Organic Greenhouse Grown Aloe Barbadensis Leaf, Panax quinquefolis L., Phenoxyethanol, Purified Water, Sodium Citrate, Sodium Lauryl Glucose Carboxylate.

PRINCIPAL DISPLAY PANEL - 180 ml Bottle Label

Nuviléo™
Acne Face Wash

Oil-free AM / PM cleanser for
Clear Skin Everyday

Non-Drying Formula

Salicylic Acid Acne Treatment

6 FL. OZ. / 180 ml.

Principal Display Panel - 180 ml Bottle Label
NUVILEO ACNE FACE WASH 
salicylic acid solution, gel forming / drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Whole (UNII: KIZ4X2EHYX)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Coco Glucoside (UNII: ICS790225B)  
Glyceryl Oleate (UNII: 4PC054V79P)  
Hydrastis Canadensis Whole (UNII: R763EBH88T)  
Lauryl Glucoside (UNII: 76LN7P7UCU)  
Panax Quinquefolius Whole (UNII: 0P067WOA1X)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Water (UNII: 059QF0KO0R)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-501-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58133-501-0390 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/30/2015
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs032973000MANUFACTURE(58133-501)

Revised: 7/2015
Document Id: b7abc303-2b67-4eb3-8949-22dca4dad33a
Set id: dd31ffbd-88ba-4af3-9c97-a3cf4d66fbfc
Version: 1
Effective Time: 20150715
 
Cosmetic Specialty Labs, Inc.