Label: ACNE RELIEF RETINOL TREATMENT AND MOISTURIZER- salicylic acid acne treatment lotion
- NDC Code(s): 45634-101-01
- Packager: NV Perricone LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 10, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
■ 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
■ 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
■ 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 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
Controls excess oil & fights
90 DAY SUPPLY
℮ 59 mL / 2 fl oz
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.
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
Dist. By: NV Perricone LLC, San Francisco,
CA 94111. Made in USA of foreign and
domestic components. 651197
1 888 823 7837
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)