ACNE RELIEF CALMING TREATMENT AND HYDRATOR- salicylic acid acne treatment lotion

ACNE RELIEF CALMING TREATMENT AND HYDRATOR by

Drug Labeling and Warnings

ACNE RELIEF CALMING TREATMENT AND HYDRATOR 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 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.

INACTIVE INGREDIENT

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

QUESTIONS

Questions 1-888-823-7837

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

INGREDIENTS AND APPEARANCE

ACNE RELIEF CALMING TREATMENT AND HYDRATOR 
salicylic acid acne treatment lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45634-102
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)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRULLINE (UNII: 29VT07BGDA)
SQUALANE (UNII: GW89575KF9)
LACTIC ACID (UNII: 33X04XA5AT)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45634-102-01	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)