ACNE RELIEF RETINOL TREATMENT AND MOISTURIZER- salicylic acid acne treatment lotion

Acne Relief Retinol Treatment and Moisturizer by

Drug Labeling and Warnings

Acne Relief Retinol Treatment and Moisturizer by is a Otc medication manufactured, distributed, or labeled by NV Perricone LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient
Salicylic Acid 0.5%

PURPOSE

Purpose
Acne Treatment

INDICATIONS & USAGE

Use
■ For the treatment of acne.

WARNINGS

Warnings
■ For external use only.
■ When Using This Product Skin irritation and dryness are
  more likely 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.

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Directions
■ Shake well. Apply a thin, even layer to skin in the evening.
  For best results, use after cleansing with ACNE RELIEF
  Gentle & Soothing Cleanser.
■ 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.
■ Sensitivity Test for a New User Apply product sparingly
  to one or two small affected areas during the first 3 days.
  If no discomfort occurs, follow the directions stated above.

INACTIVE INGREDIENT

Inactive Ingredients Water/Aqua/Eau, SD Alcohol 40-B,
Glycerin, Dicaprylyl Ether, Niacinamide, Citrulline, Arginine, Methyl
Gluceth-20, Cetearyl Alcohol, Carbomer, Xanthan Gum, Tocopheryl
Acetate, Retinol, Citric Acid, Sodium Hydroxide, Disodium
EDTA, PEG-20 Methyl Glucose Sesquistearate, PEG-100 Stearate,
Glyceryl Stearate, Methyl Glucose Sesquistearate, Polysorbate
20, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

QUESTIONS

Questions 1-888-823-7837

Product Package

ACNE RELIEF

Retinol Treatment
& Moisturizer

Controls excess oil & fights
blemishes overnight

STEP 2
NIGHT

Perricone MD

ACNE RELIEF
Retinol Treatment
& Moisturizer

Salicylic Acid
Acne Treatment

90 DAY SUPPLY

Niacinamide, Citrulline,
Retinol

℮ 59 mL / 2 fl oz

KEY INGREDIENTS
Niacinamide: Gentle Skin-
Clearing Multi-Tasker Also
known as vitamin B3 & found in
foods such as tomatoes, this skin-
clearing powerhouse helps to
gently & visibly erase imperfections,
unclog oily pores & minimize
redness & uneven skin tone that
can be left behind after breakouts
by improving skin’s moisture
barrier. B3 is a powerful antioxidant
& an essential nutrient
that plays a key role in many of
the body’s basic functions.

Citrulline: Fight Irritation &
Visibly Reduce Redness First
discovered in watermelon, this
alpha-amino acid visibly calms
skin for a clearer, more even-
looking complexion. Nourishing
& soothing, it is an ideal way to
counteract the irritating effects
of anti-acne ingredients.

Retinol: Exfoliate for Clearer
Skin & Accelerated Rejuvenation
This ultra-powerful, non-prescription
vitamin A derivative helps
prevent breakouts by unclogging
pores & accelerating surface skin
exfoliation & renewal. Unique
slow-release carrier system helps
preserve this unstable ingredient
& calm skin.

Expiration &
Lot Code area

Perricone MD ACNE RELIEF
Prebiotic Acne Therapy is a
simple, comprehensive system
that works with your surface
skin’s natural microbiome to
safely, gently & effectively treat
& prevent the most troublesome
acne, while restoring &
maintaining a healthy skin
balance, for clearer, blemish-
free skin. This powerful 2-step
regimen is clinically proven to
be non-irritating & will not
strip or over-dry skin.

The Retinol Treatment & Moisturizer
is Step 2 in your night
regimen, after cleansing. The
lightweight yet nourishing
formula absorbs instantly to
control excess oil & helps to
heal blemishes while you sleep
without over-drying the skin.
The powerful combination of
retinol, citrulline & niacinamide
helps to accelerate surface
skin exfoliation & renewal, visibly
calm skin & reduce redness,
while gently & visibly erasing
imperfections overnight.

Dist. By: NV Perricone LLC, San Francisco,
CA 94111. Made in USA of foreign and
domestic components. 651197

1 888 823 7837
perriconemd.com

Outer Box

Bottle

rege

INGREDIENTS AND APPEARANCE

ACNE RELIEF RETINOL TREATMENT AND MOISTURIZER 
salicylic acid acne treatment lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45634-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.295 g  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
NIACINAMIDE (UNII: 25X51I8RD4)
CITRULLINE (UNII: 29VT07BGDA)
ARGININE (UNII: 94ZLA3W45F)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM BENZOATE (UNII: OJ245FE5EU)
RETINOL (UNII: G2SH0XKK91)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45634-101-01	1 in 1 PACKAGE	08/01/2019
1		59 mL in 1 BOTTLE, DROPPER; 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	08/01/2019

Labeler - NV Perricone LLC (054414243)

Registrant - NV Perricone LLC (054414243)