ACNE RELIEF MAXIMUM STRENGTH SPOT GEL- salicylic acid acne treatment gel

Acne Relief Maximum Strength Spot Gel by

Drug Labeling and Warnings

Acne Relief Maximum Strength Spot Gel 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 2.0%

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 ■ 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, Propanediol, Hamamelis
Virginiana (Witch Hazel) Water, Glycerin,
Sucrose, Citrulline, Hydroxyethylcellulose,
Urea, Panthenol, Lactic Acid, Melaleuca
Alternifolia (Tea Tree) Leaf Oil, Sodium Hydroxide,
Tetrasodium Glutamate Diacetate,
Succinic Acid, Alcohol, Polysorbate 20

QUESTIONS

Questions1-888-823-7837

Product Package

ACNE RELIEF
Maximum Strength Spot Gel
Minimizes blemishes & helps prevent
future breakouts

Perricone MD

ACNE RELIEF

Maximum
Strength
Spot Gel

Salicylic Acid
Acne Treatment

90 DAY SUPPLY

Lactic & Succinic Acids,
Citrulline, Tea Tree Oil

℮ Net Wt 0.5oz / 14.1 g

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 exfoliation 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 antiacne
ingredients.

Tea Tree Oil: Cleanse,
Clarify & Soothe This
powerful essential oil
helps visibly reduce
redness & calm skin.
It easily penetrates
skin’s surface, features
a light, refreshing scent
similar to eucalyptus
& has been used for
centuries in traditional
Australian medicine.

This maximum strength invisible gel works
overtime to reduce blemishes & prevent
future breakouts by killing acne-causing
bacteria, unclogging pores & absorbing
excess oil without over-drying.

Dist. By: NV Perricone LLC, San Francisco,
CA 94111. Made in USA of foreign and
domestic components. 651199

1 888 823 7837 perriconemd.com

Expiration &
Lot Code area

Outer Box

Tube

rege

INGREDIENTS AND APPEARANCE

ACNE RELIEF MAXIMUM STRENGTH SPOT GEL 
salicylic acid acne treatment gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45634-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPANEDIOL (UNII: 5965N8W85T)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE (UNII: C151H8M554)
CITRULLINE (UNII: 29VT07BGDA)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
UREA (UNII: 8W8T17847W)
PANTHENOL (UNII: WV9CM0O67Z)
LACTIC ACID (UNII: 33X04XA5AT)
TEA TREE OIL (UNII: VIF565UC2G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SUCCINIC ACID (UNII: AB6MNQ6J6L)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45634-100-01	1 in 1 PACKAGE	08/01/2019
1		14.1 g in 1 TUBE; 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)