NUVILEO SKIN PERFECTING ACNE- salicylic acid cream 
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™ Skin Perfecting Acne Cream

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

Apply thin layer of cream on affected skin surface.

Inactive ingredients

Allantoin, Aloe Barbadensis Leaf, Aloe barbadensis mill, C13-14 Isoparaffin, Caprylyl Glycol, Citrus Grandis (Grapefruit) Peel Oil, Cyclomethicone, Disodium EDTA, Emulsifying Wax, Ethylhexyl Stearate, Hydrastis canadensis L., Laureth-7, Olea Europaea (Olive) Fruit Oil, Panax quinquefolius L., Passiflora Incarnata, Phenoxyethanol, Polyacrylamide, Purified Water, Sorbitol, Tocopheryl Acetate, Triethanolamine

PRINCIPAL DISPLAY PANEL - 60 ml Tube Label

Nuviléo

Skin Perfecting
Acne Cream

Residue free acne cream for
Clear Skin Everyday

Salicylic Acid Acne Treatment

2 FL. OZ. / 60 ml.

Principal Display Panel - 60 ml Tube Label
NUVILEO SKIN PERFECTING ACNE 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-500
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
Allantoin (UNII: 344S277G0Z)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Aloe Vera Whole (UNII: KIZ4X2EHYX)  
C13-14 Isoparaffin (UNII: E4F12ROE70)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
Cyclomethicone (UNII: NMQ347994Z)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
Hydrastis Canadensis Whole (UNII: R763EBH88T)  
Laureth-7 (UNII: Z95S6G8201)  
Olive Oil (UNII: 6UYK2W1W1E)  
Panax Quinquefolius Whole (UNII: 0P067WOA1X)  
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-500-0260 mL in 1 TUBE; 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 Labs 032973000MANUFACTURE(58133-500)

Revised: 7/2015
Document Id: 230eff3b-ad49-4729-8b6c-2bd56e15b61b
Set id: 731c60f5-8b27-41d6-baaf-1f4723e92aa9
Version: 1
Effective Time: 20150715
 
Cosmetic Specialty Labs, Inc.