FDA.reportPublic FDA data

THE BETTER SKIN CO. ® ZIT NO MORE KLEANSE

Manufacturer
Mirakle Cosmetics LLC dbaThe Better Skin Co. | Innovative Cosmetic Labs
Effective date
2020-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:33

Label at a glance#

ProductTHE BETTER SKIN CO. ZIT NO MORE KLEANSE
Active ingredientsalicylic acid
Label structure9 sections

Indications and uses

for the treatment of acne clears up acne blemishes and acne pimples and allows skin to heal penetrates pores to clear most acne blemishes helps keep skin clear of new acne pimples helps prevent new acne pimples

Dosage and administration

use twice a day, morning and night lather between palms with water, Massage in circular motion on wet skin. Rinse well because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 prod...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment gel

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • clears up acne blemishes and acne pimples and allows skin to heal
  • penetrates pores to clear most acne blemishes
  • helps keep skin clear of new acne pimples
  • helps prevent new acne pimples

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • use twice a day, morning and night
  • lather between palms with water, Massage in circular motion on wet skin. Rinse well
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 first 3 days. If no discomfort occurs, follow directions above

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Sodium Methyl Cocoyl Taurate, Cocamidopropyl Hydroxysultaine, Sodium Lauroyl Lactylate, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Hydroxide, Menthol, Saccharomyces/Xylinum/Black Tea Ferment, Phenoxyethanol, Ethylhexylglycerin.

Questions or comments?

OTC - QUESTIONS SECTION

Visit us at www.thebetterskinco.com, email ZitNoMore@thebetterskinco.com or call (310) 994-4490 Monday – Friday 8 a.m. – 5 p.m. PST

PRINCIPAL DISPLAY PANEL - 163 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THE BETTER SKIN CO.®
ZIT NO MORE KLEANSE

GEL KLEANSE ACNE TREATMENT

POWERED BY
TEA TREE + KOMBUCHA
SALICYLIC ACID

163 mL ℮ /5.5 fl. OZ

PRINCIPAL DISPLAY PANEL - 163 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 163 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691004salicylic acid 5.7 % Topical GelPSN1
2691004salicylic acid 0.057 MG/MG Topical GelSCD1
2691004salicylic acid 5.7 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71716-101-022021-07-23C16284748780-1c7ccaba7-1fbc-fd44-e053-dadaa90aa01bTHE BETTER SKIN CO. ® ZIT NO MORE KLEANSE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71716-101-02THE BETTER SKIN CO. ZIT NO MORE KLEANSE163 mL in 1 BOTTLEGEL1631

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71716-101THE BETTER SKIN CO. ZIT NO MORE KLEANSE (SALICYLIC ACID) GEL [MIRAKLE COSMETICS LLC DBATHE BETTER SKIN CO.]1Legacy NDC, 1 package rows20200630_da4e3066-95a1-456e-83a9-96a7593f7598.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71716-10171716-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
salicylic acidO414PZ4LPZACTIB
WATER059QF0KO0RIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
39f66943-fe46-401c-ac8a-fef41b37adbfda4e3066-95a1-456e-83a9-96a7593f75982020-06-26WarningsExact identifier
spl id: 39f66943-fe46-401c-ac8a-fef41b37adbf
spl set id: da4e3066-95a1-456e-83a9-96a7593f7598

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.