Label: ACNE RELIEF MAXIMUM STRENGTH SPOT GEL- salicylic acid acne treatment gel
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Contains inactivated NDC Code(s)
NDC Code(s): 45634-100-01 - 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
- PURPOSE
- INDICATIONS & USAGE
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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
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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
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Product Package
ACNE RELIEF
Maximum Strength Spot Gel
Minimizes blemishes & helps prevent
future breakoutsPerricone MD
ACNE RELIEF
Maximum
Strength
Spot GelSalicylic Acid
Acne Treatment90 DAY SUPPLY
Lactic & Succinic Acids,
Citrulline, Tea Tree Oil℮ Net Wt 0.5oz / 14.1 g
KEY
INGREDIENTSLactic & 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. 6511991 888 823 7837 perriconemd.com
Expiration &
Lot Code areaOuter Box
Tube
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INGREDIENTS AND APPEARANCE
ACNE RELIEF MAXIMUM STRENGTH SPOT GEL
salicylic acid acne treatment gelProduct 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)