Acne Relief Calming Treatment & Hydrator Step 2 - Day

Acne Relief Calming Treatment & Hydrator Step 2 - Day
SPL v2
SPL
SPL Set ID 68ca7c59-afa4-4260-bc15-a7ebac372d1f
Route
TOPICAL
Published
Effective Date 2019-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.295 g)
Inactive Ingredients
Water Alcohol Glycerin C12-15 Alkyl Lactate Povidone, Unspecified Dimethicone Polysorbate 20 Citrulline Squalane Lactic Acid Succinic Acid Polyacrylamide (10000 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) C13-14 Isoparaffin Laureth-7 Phenoxyethanol Sodium Benzoate Potassium Sorbate

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 morning.

   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, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysor-

bate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Poly-

acrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer,

C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzo-

atr, 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

Calming Treatment

& Hydrator

Nourishes, hydrates & visibly

reduces redness

STEP 2

DAY

Perricone MD

ACNE RELIEF

90 DAY SUPPLY

Lactic & Succinic Acids,

Citrulline, Squalane

℮ 59 mL / 2 fl oz

KEY INGREDIENTS

Lactic & Succinic Acids: Attack

Acne-Causing Bacteria These

short-chain fatty acids help quickly

shrink blemishes by working

alongside salicylic acid to attack

acne-causing bacteria for a healthier

skin microbiome. They also

provide gentle yet effective ex-

foliation for smoother, more even=

looking skin.

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.

Squalane: Hydrate & Nourish

Found naturally in the human

body & derived from olive oil,

squalane hydrates without making

skin look or feel greasy. This lightweight

hydration is ideal for oil

& acne-prone skin as it helps

maintain optimal hydration without

clogging pores or causing

blemishes.

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 Calming Treatment &

Hydrator is Step 2 in your day or

morning regimen, after cleans-

ing, The lightweight lotion

glides onto skin to gently kill

acne-causing bacteria, while

nourishing with essential hy-

dration.  Lactic & succinic acids

support a healthy surface skin

microbiome for a clearer, more

radiant complexion, while citrul-

line & squalane fight irritation,

nourish, hydrate, soothe & vis-

ibly reduce redness.

Dist. By: NV Perricone LLC, San Francisco,

CA 94111. Made in USA of foreign and

domestic components. 651196

1 888 823 7837

perriconemd.com

Expiration &

Lot Code area

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 morning.

   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, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysor-

bate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Poly-

acrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer,

C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzo-

atr, 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

Calming Treatment

& Hydrator

Nourishes, hydrates & visibly

reduces redness

STEP 2

DAY

Perricone MD

ACNE RELIEF

90 DAY SUPPLY

Lactic & Succinic Acids,

Citrulline, Squalane

℮ 59 mL / 2 fl oz

KEY INGREDIENTS

Lactic & Succinic Acids: Attack

Acne-Causing Bacteria These

short-chain fatty acids help quickly

shrink blemishes by working

alongside salicylic acid to attack

acne-causing bacteria for a healthier

skin microbiome. They also

provide gentle yet effective ex-

foliation for smoother, more even=

looking skin.

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.

Squalane: Hydrate & Nourish

Found naturally in the human

body & derived from olive oil,

squalane hydrates without making

skin look or feel greasy. This lightweight

hydration is ideal for oil

& acne-prone skin as it helps

maintain optimal hydration without

clogging pores or causing

blemishes.

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 Calming Treatment &

Hydrator is Step 2 in your day or

morning regimen, after cleans-

ing, The lightweight lotion

glides onto skin to gently kill

acne-causing bacteria, while

nourishing with essential hy-

dration.  Lactic & succinic acids

support a healthy surface skin

microbiome for a clearer, more

radiant complexion, while citrul-

line & squalane fight irritation,

nourish, hydrate, soothe & vis-

ibly reduce redness.

Dist. By: NV Perricone LLC, San Francisco,

CA 94111. Made in USA of foreign and

domestic components. 651196

1 888 823 7837

perriconemd.com

Expiration &

Lot Code area

Outer Box

Bottle

rege


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