Spot Stopper Acne Spot Treatment

Manufacturer
The Honest Company, Inc
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:01

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Salicylic Acid 2%

OTC - PURPOSE SECTION

Purpose Acne treatment

Uses

INDICATIONS & USAGE SECTION

Use ♦ For the treatment of acne.

Warnings

WARNINGS SECTION

Warnings For external use only.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

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.

Other Label Information

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Label Images#

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN2
346298salicylic acid 0.02 MG/MG Topical GelSCD2
346298salicylic acid 2 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69366-412-322023-12-19C16284748780-10191ceaa-621d-198a-e063-dbdaa90aec3eSpot Stopper Acne Spot Treatment
69366-412-322023-07-28C16284748780-10191ceaa-621d-198a-e063-dbdaa90aec3eSpot Stopper Acne Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69366-412-32Spot Stopper Acne Spot Treatment1 in 1 CARTONGEL12
69366-412-32Spot Stopper Acne Spot Treatment15 mL in 1 TUBEGEL152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69366-412SPOT STOPPER ACNE SPOT TREATMENT (SALICYLIC ACID) GEL [THE HONEST COMPANY, INC]2Current NDC, Legacy NDC, 2 package rows20231220_dc7afebd-e212-b9ff-e053-2a95a90a15a5.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69366-41269366-412-32

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Salicylic Acid 2%

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Acne treatment

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Use ♦ For the treatment of acne.

WARNINGS SECTION

WARNINGS SECTION

Warnings For external use only.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Other information Store in dry, cool conditions.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

HOW TO USE ME Gently tap a pea-sized amount onto active blemishes and let me dry. If using in the AM, feel free to apply makeup on top.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Source Document#

Source XML