Acne Relief Retinol Treatment & Moisturizer  

Acne Relief Retinol Treatment & Moisturizer  
SPL v2
SPL
SPL Set ID 0d709c0f-aacb-4f97-8f77-4fe924a58949
Route
TOPICAL
Published
Effective Date 2019-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.295 g)
Inactive Ingredients
Water Alcohol Glycerin Dicaprylyl Ether Niacinamide Citrulline Arginine Methyl Gluceth-20 Cetostearyl Alcohol Carboxypolymethylene Phenoxyethanol Citric Acid Monohydrate Peg-20 Methyl Glucose Sesquistearate Peg-100 Stearate Glyceryl Monostearate Methyl Glucose Sesquistearate Xanthan Gum Sodium Hydroxide .alpha.-tocopherol Acetate Sodium Benzoate Retinol Polysorbate 20 Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-08-01

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and Usage

Use

■ For the treatment of acne.

Dosage and 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.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 51727-6

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

Section 53413-1

Questions 1-888-823-7837

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active Ingredient

Salicylic Acid 0.5%

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


Structured Label Content

Indications and Usage (34067-9)

Use

■ For the treatment of acne.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions 1-888-823-7837

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid 0.5%

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


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Raw Label Data

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