NUVILEO ACNE FACE WASH- salicylic acid solution, gel forming / drops

Nuvileo Acne Face Wash by

Drug Labeling and Warnings

Nuvileo Acne Face Wash by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc., Cosmetic Specialty Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Reduces redness
• Clears breakouts
• Gently exfoliates skin
• Removes excess oil, dirt & makeup

Salicylic Acid Acne Treatment

6 FL. OZ. / 180 ml.

INGREDIENTS AND APPEARANCE

NUVILEO ACNE FACE WASH 
salicylic acid solution, gel forming / drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-501-06	180 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58133-501-03	90 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/30/2015

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs		032973000	MANUFACTURE(58133-501)