Spot Stopper Acne Spot Treatment

Spot Stopper Acne Spot Treatment
SPL v2
SPL
SPL Set ID dc7afebd-e212-b9ff-e053-2a95a90a15a5
Route
TOPICAL
Published
Effective Date 2022-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Propanediol Hamamelis Virginiana Top Water Sodium Citrate Glycolic Acid Isopentyldiol Alcohol Silicon Dioxide Water 1,2-hexanediol Caprylyl Glycol Hydroxyacetophenone Allantoin Sodium Hydroxide Xanthan Gum Trisodium Ethylenediamine Disuccinate Anhydrous Citric Acid Chlorella Vulgaris Lactic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Active ingredient Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warnings

For external use only.

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.

Description

Active ingredient Salicylic Acid 2%

Section 42229-5

Other information

Store in dry, cool conditions.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

♦ skin irritation and dryness is 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.

♦ avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 51727-6

Inactive ingredients

Water (Aqua/Eau), Propanediol, Hamamelis Virginiana (Witch Hazel) Water, Sodium Citrate, Glycolic Acid, Isopentyldiol, Alcohol, Silica, Hydroxyaceto-phenone, Allantoin, Sodium Hydroxide, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Trisodium Ethylenediamine Disuccinate, Chlorella Vulgaris Extract, Lactic Acid, Citric Acid.

Section 51945-4

HONEST ®

SPOT STOPPER ACNE SPOT TREATMENT

NIX THE SPOT

Wintergreen Derived Salicylic Acid + Witch Hazel

0.5 fl. oz. / 15 mL

HONEST.COM

or call 888-862-8818

©2022 Dist. by

The Honest Company, Inc.

Los Angeles, CA 90094

Made in USA from US and imported materials

Section 55105-1

Purpose Acne treatment

Section 55106-9

Active ingredient Salicylic Acid 2%


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.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Other information

Store in dry, cool conditions.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

♦ skin irritation and dryness is 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.

♦ avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 51727-6 (51727-6)

Inactive ingredients

Water (Aqua/Eau), Propanediol, Hamamelis Virginiana (Witch Hazel) Water, Sodium Citrate, Glycolic Acid, Isopentyldiol, Alcohol, Silica, Hydroxyaceto-phenone, Allantoin, Sodium Hydroxide, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Trisodium Ethylenediamine Disuccinate, Chlorella Vulgaris Extract, Lactic Acid, Citric Acid.

Section 51945-4 (51945-4)

HONEST ®

SPOT STOPPER ACNE SPOT TREATMENT

NIX THE SPOT

Wintergreen Derived Salicylic Acid + Witch Hazel

0.5 fl. oz. / 15 mL

HONEST.COM

or call 888-862-8818

©2022 Dist. by

The Honest Company, Inc.

Los Angeles, CA 90094

Made in USA from US and imported materials

Section 55105-1 (55105-1)

Purpose Acne treatment

Section 55106-9 (55106-9)

Active ingredient Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

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