SPL v2
SPL
SPL Set ID 6c27e2cb-9c8d-4695-8832-61c474474be9
Route
TOPICAL
Published
Effective Date 2019-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Alcohol Propanediol Hamamelis Virginiana Top Water Glycerin Sucrose Citrulline Hydroxyethyl Cellulose (100 Mpa.s At 2%) Urea Panthenol Lactic Acid Tea Tree Oil Sodium Hydroxide Tetrasodium Glutamate Diacetate Succinic Acid Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-08-01

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and Usage

Use ■ For the treatment of acne.

Dosage and 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.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 51727-6

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

Section 53413-1

Questions 1-888-823-7837

Section 55105-1

Purpose

Acne Treatment

Section 55106-9

Active Ingredient

Salicylic Acid 2.0%

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


Structured Label Content

Indications and Usage (34067-9)

Use ■ For the treatment of acne.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions 1-888-823-7837

Section 55105-1 (55105-1)

Purpose

Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid 2.0%

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


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