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Drug Facts
Acne Relief Maximum Strength Spot Gel
FDA Label NDC 45634-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nv Perricone Llc for the product Acne Relief Maximum Strength Spot Gel (NDC 45634-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Salicylic Acid 2.0%
Otc - 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.
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
Otc - 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
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