FDA.reportPublic FDA data

Stay Pure Acne Treatment Lotion

Manufacturer
Aloette
Effective date
2019-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:26

Label at a glance#

ProductStay Pure Acne Treatment
Active ingredientSalicylic Acid
Label structure10 sections

Indications and uses

For the treatment of acne.

Dosage and administration

Cleanse the skin thoroughly before applying the medication Cover the entire affected area with a thin layer one to three times daily or as directed by a health care professional Because excessive drying of the skin may occur, start with one application daily and then gradually increase to two or three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other da...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Medicinal Ingredient/Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0% w/w

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

  • When using this product with other topical acne medications at the same time or immediately following use of this product, may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a health care practitioner
  • Avoid contact with eyes; If contact occurs, rinse with water to remove

OTC - STOP USE SECTION

  • Discontinue use if excessive skin irritation develops or increases. If irritation persists, consult a health care practitioner.

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

Cleanse the skin thoroughly before applying the medication

  • Cover the entire affected area with a thin layer one to three times daily or as directed by a health care professional
  • Because excessive drying of the skin may occur, start with one application daily and then gradually increase to two or three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Keep carton for additional directions and warning information.

Non-Medicinal Ingredients/Inactive Ingredients

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF JUICE, AQUA, ALCOHOL DENAT., GLYCERIN, TAPIOCA STARCH, CYCLOPENTASILOXANE, DIMETHICONE, DICAPRYLYL CARBONATE, AMMONIUM ACRYLOYLDIMETHYLTA URATE/VP COPOLYMER, ALOE BARBADENSIS LEAF EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, CAMELIA SINENSIS EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, SUPEROXIDE DISMUTASE, NORDIHYDROGUAIARE TIC ACID, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, BISABOLOL, MALTODEXTRIN, ORYZA SATIVA (RICE) BRAN EXTRACT, LAURYL GLUCOSIDE, POLYQUATERNIUM-28, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Question or comments?

OTC - QUESTIONS SECTION

Call 1.800.Aloette or visit www.Aloette.com

SPL UNCLASSIFIED SECTION

Distributed by Aloette Cosmetics Inc. Atlanta, GA 30327

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aloeclear™

3

Stay Pure

Acne Treatment Lotion

Salicylic Acid 2.0% w/w
NPN 80054497
0.5 FL OZ/15 mL

TREAT

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103568salicylic acid 2 % Topical LotionPSN2
103568salicylic acid 20 MG/ML Topical LotionSCD2
103568salicylic acid 2 % Topical LotionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65447-377-002021-01-29C16284748780-1ba0f9c33-21bf-a910-e053-dadaa90a0b85Stay Pure Acne Treatment Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65447-377-00Stay Pure Acne Treatment1 in 1 CARTONLOTION12
65447-377-00Stay Pure Acne Treatment15 mL in 1 TUBELOTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65447-377STAY PURE ACNE TREATMENT (SALICYLIC ACID) LOTION [ALOETTE]2Legacy NDC, 2 package rows20191228_e33d9032-e905-4b7d-9c1f-375e7043036e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LAURYL GLUCOSIDEINACTIVE INGREDIENT76LN7P7UCU1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
MASOPROCOLINACTIVE INGREDIENT7BO8G1BYQU1
MUSKMELONINACTIVE INGREDIENTZV095H56331
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYQUATERNIUM-28 (1100000 MW)INACTIVE INGREDIENT6M8B654MEQ1
RICE BRANINACTIVE INGREDIENTR60QEP13IC1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704I1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65447-37765447-377-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
STARCH, TAPIOCA24SC3U704IIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SHEA BUTTERK49155WL9YIACT
CHAMOMILEFGL3685T2XIACT
MUSKMELONZV095H5633IACT
MASOPROCOL7BO8G1BYQUIACT
TEA TREE OILVIF565UC2GIACT
LEVOMENOL24WE03BX2TIACT
MALTODEXTRIN7CVR7L4A2DIACT
RICE BRANR60QEP13ICIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
POLYQUATERNIUM-28 (1100000 MW)6M8B654MEQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 161 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, FILM COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates

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
bfb36c91-9d1d-4862-a532-1e98d351854ee33d9032-e905-4b7d-9c1f-375e7043036e2019-12-27WarningsExact identifier
spl id: bfb36c91-9d1d-4862-a532-1e98d351854e
spl set id: e33d9032-e905-4b7d-9c1f-375e7043036e

Reported adverse events (FAERS/openFDA)#

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