FDA.reportPublic FDA data

PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC

Manufacturer
Naturopathica Holistic Health
Effective date
2024-05-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:13:14

Label at a glance#

ProductPRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC
Active ingredientSALICYLIC ACID
Label structure11 sections

Dosage and administration

Shake well before use. Cleanse skin thoroughly before applying this product. Dispense onto cotton pad and sweep over face, neck and chest. Avoid immediate eye area. Do not rinse. 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 onc...

Storage and handling

Store at Room Temperature. Keep out of direct sunlight after use. Do not freeze.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • for the management of acne.
  • Penetrates pores to eliminate most acne blemishes.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • Do not use if you have very sensitive skin or are sensitive to Salicylic Acid.
  • skin irritation and dryness may occur if you use another topical acne medication at the same time or immediately following. If irritation occurs, only use one topical acne medication at a time unless directed by a doctor.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If irritation becomes severe.

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

  • Shake well before use.
  • Cleanse skin thoroughly before applying this product.
  • Dispense onto cotton pad and sweep over face, neck and chest. Avoid immediate eye area. Do not rinse.
  • 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 Information

STORAGE AND HANDLING SECTION

Store at Room Temperature. Keep out of direct sunlight after use. Do not freeze.

Sunburn Alert

SPL UNCLASSIFIED SECTION

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice ,Glycolic Acid, Sorbitan Oleate Decylglucoside Crosspolymer, Gluconolactone, Dimethyl Isosorbide, Sodium PCA, Glycerin, Sodium Benzoate, Betaine, Citrus Limon (Lemon) Peel Oil, Hibiscus Sabdariffa Flower Extract, Opuntia Ficus-Indica Stem Extract, Sodium Hyaluronate, Calcium Gluconate ,Chlorophyllin-Copper Complex, Rosmarinus Officinalis (Rosemary) Leaf Oil ,Mentha Viridis (Spearmint) Leaf Oil ,Sodium Hydroxide ,Limonene.

Questions or Comments?

OTC - QUESTIONS SECTION

call toll free 646-979-3997

SPL UNCLASSIFIED SECTION

Distributed by:
Naturopathica Holistic Health
New York, NY 10001.

PRINCIPAL DISPLAY PANEL - 150 ML Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NATUROPATHICA ®
FOR DEEPER BEAUTY

PRICKLY PEAR &
SALICYLIC ACID
ACNE CLEARING
TONIC

5 FL OZ / 150 ML

PRINCIPAL DISPLAY PANEL - 150 ML Bottle Carton
PRINCIPAL DISPLAY PANEL - 150 ML Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251577salicylic acid 2 % Topical SolutionPSN2
251577salicylic acid 20 MG/ML Topical SolutionSCD2
251577salicylic acid 2 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64657-003-012026-01-29C16284748780-1f386c649-f1db-0266-e053-dadaa90a7c1aPRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC
64657-003-032026-01-29C16284748780-1f386c649-f1db-0266-e053-dadaa90a7c1aPRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC
64657-003-012024-05-30C16284748780-1f386c649-f1db-0266-e053-dadaa90a7c1aPRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC
64657-003-032024-05-30C16284748780-1f386c649-f1db-0266-e053-dadaa90a7c1aPRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC
64657-003-012023-01-30C16284748780-1f386c649-f1db-0266-e053-dadaa90a7c1aPRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC
64657-003-032023-01-30C16284748780-1f386c649-f1db-0266-e053-dadaa90a7c1aPRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64657-003-01PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC150 mL in 1 BOTTLE, PUMPLIQUID1502
64657-003-01PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC1 in 1 CARTONLIQUID12
64657-003-03PRICKLY PEAR and SALICYLIC ACID ACNE CLEARING TONIC150 mL in 1 BOTTLE, GLASSLIQUID1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64657-003PRICKLY PEAR AND SALICYLIC ACID ACNE CLEARING TONIC (SALICYLIC ACID) LIQUID [NATUROPATHICA HOLISTIC HEALTH]2Legacy NDC, 3 package rows20240601_9345456f-a16b-47fd-a1a5-7d4b0bcc1c7f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64657-00364657-003-01, 64657-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCOLIC ACID0WT12SX38SIACT
GLUCONOLACTONEWQ29KQ9POTIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
BETAINE3SCV180C9WIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
OPUNTIA FICUS-INDICA STEMMUD8892KHLIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CALCIUM GLUCONATESQE6VB453KIACT
SODIUM COPPER CHLOROPHYLLIN1D276TYV9OIACT
ROSEMARY OIL8LGU7VM393IACT
SPEARMINT OILC3M81465G5IACT
SODIUM HYDROXIDE55X04QC32IIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
19abf9f3-852a-2504-e063-6394a90a79709345456f-a16b-47fd-a1a5-7d4b0bcc1c7f2024-05-30WarningsExact identifier
spl id: 19abf9f3-852a-2504-e063-6394a90a7970
spl set id: 9345456f-a16b-47fd-a1a5-7d4b0bcc1c7f

Reported adverse events (FAERS/openFDA)#

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