Nuvileo Acne Face Wash: Package Insert and Label Information

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.

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.

Principal Display Panel -- 180 ml Bottle Label
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Aloe Vera Whole
Caprylyl Glycol
Cocamidopropyl Betaine
Coco Glucoside
Glyceryl Oleate
Hydrastis Canadensis Whole
Lauryl Glucoside
Panax Quinquefolius Whole
Phenoxyethanol
Water
Sodium Citrate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58133-501-06 180 mL in 1 BOTTLE None
2 NDC:58133-501-03 90 mL in 1 BOTTLE None
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 Operations
Cosmetic Specialty Labs 032973000 MANUFACTURE (58133-501)

Revised: 07/2015 Cosmetic Specialty Labs, Inc.

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