Label: ACNE RELIEF CALMING TREATMENT AND HYDRATOR- salicylic acid acne treatment lotion
- NDC Code(s): 45634-102-01
- 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.
Drug Label Information
Updated February 10, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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 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
■ 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, 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
Nourishes, hydrates & visibly
90 DAY SUPPLY
Lactic & Succinic Acids,
℮ 59 mL / 2 fl oz
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=
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
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
Lot Code area
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)