FDA.reportPublic FDA data

ACNE FORMULA

Manufacturer
Volans Epic LLC | PONTIKA AEROTECH LIMITED
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:25

Label at a glance#

ProductACNE FORMULA
Active ingredientSALICYLIC ACID, HYALURONATE SODIUM, NIACINAMIDE, ZINC GLUCONATE, MENTHOL
Label structure11 sections

Dosage and administration

Wash your face with a cleanser. Use a pea-sized amount to dot the 5 in 1 Acne Formula Face Moisturizer on your cheeks, forehead, nose and under-eye. Gently massage it into your skin.

Label contents#

Full prescribing information#

Active Ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.5%, Sodium Hyaluronate 0.05%, Niacinamide 2.0%, Zinc Gluconate 0.5%, Menthol 0.03% ---------------For acne

Use

OTC - PURPOSE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

FOR EXTERNAL USEONLY.

When using this product

INDICATIONS & USAGE SECTION

■ Avoid contact with eyes. If contact occurs, flush thoroughly with water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help.
Patch Test Recommended.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Wash your face with a cleanser. Use a pea-sized amount to dot the 5 in 1 Acne Formula Face Moisturizer on your cheeks, forehead, nose and under-eye. Gently massage it into your skin.

Other lnformation

SPL UNCLASSIFIED SECTION

Store in a cool & dry place. Keep away from direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Dipropylene Glycol, Sodium Acrylates Copolymer and Lecithin, PEG-100 Stearate and Glyceryl Stearate, Purified Talc, Hydroxypropyl Starch Phosphate, Isododecane, C13-15 Alkane, Titanium Dioxide, Phenoxyethanol, Sodium Hydroxide, Hydroxyethyl cellulose, Citric Acid Monohydrate, Fragrance, Tetra Sodium EDTA

Questions or Comments?

OTC - QUESTIONS SECTION

For any customer feedback or queries,
write to us at: info@majesticpure.com or call us on +1 530-464-6426

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY & DOMESTIC REPRESENTATIVE ADDRESS:
Volans Epic LLC
Corporation Trust Center, 1209 Orange Street, Wilmington,
Delaware 19801, Country of New Castle

MANUFACTURED BY:
Pontika Aerotech Limited
Village Johron, PO Puruwala, Nahan Road, Paonta Sahib District
Sirmour, Himachal Pradesh-173001, India

Mfg.Lic.No.:N-COS/18/47

Made in India

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83325-004-01ACNE FORMULA50 g in 1 BOTTLECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83325-004ACNE FORMULA CREAM [VOLANS EPIC LLC]11 package rows20240208_d2db13e4-34e3-4906-89a8-1e1ef9302b50.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83325-00483325-004-01

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
DIPROPYLENE GLYCOLE107L85C40IACT
SODIUM ACRYLATE7C98FKB43HIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
TALC7SEV7J4R1UIACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT
ISODODECANEA8289P68Y2IACT
C13-15 ALKANE114P5I43UJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROXYMETHYL CELLULOSE273FM27VK1IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FRAGRANCE 135765EM498GW35IACT
EDETATE SODIUMMP1J8420LUIACT
SALICYLIC ACIDO414PZ4LPZACTIB
HYALURONATE SODIUMYSE9PPT4THACTIB
NIACINAMIDE25X51I8RD4ACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
MENTHOLL7T10EIP3AACTIB

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
10c9eb9d-61a5-4df1-e063-6394a90a2f52d2db13e4-34e3-4906-89a8-1e1ef9302b502024-02-07WarningsExact identifier
spl id: 10c9eb9d-61a5-4df1-e063-6394a90a2f52
spl set id: d2db13e4-34e3-4906-89a8-1e1ef9302b50

Reported adverse events (FAERS/openFDA)#

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