FDA.reportPublic FDA data

BOTA C Reset

Manufacturer
JB.MONSTER PTY LTD | D & H INTERNATIONAL PTY LTD
Effective date
2021-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:07

Label at a glance#

ProductBOTA C Reset
Active ingredientNiacinamide, Adenosine
Label structure10 sections

Indications and uses

■ Helps brighten skin tone and improve wrinkles to disappear. ■ Hydrates and calms skin.

Dosage and administration

■ After using the BOTA C Ascorbic Acid Ampoule, apply an appropriate amount and gently pat into skin. ■ Increase the effects of vitamin C by frequently reapplying the BOTA C Reset Cream.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Niacinamide 2%
Adenosine 0.04%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Centella Asiatica Leaf Water, Water, Butylene Glycol, 1,2-Hexanediol, Caprylic/Capric Triglyceride, Macadamia Ternifolia Seed Oil, Glycerin,
Cetearyl Alcohol, Butylene Glycol Dicaprylate / Dicaprate, Propanediol, Octyldodecanol, Stearyl Alcohol, Centella Asiatica Extract, Beeswax, Panthenol, Carbomer, Glyceryl Stearate, Tromethamine, Cetearyl Olivate, Citrus Aurantifolia (lime) Fruit Extract, Sorbitan Olivate, Alcohol, Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Hydrogenated Jojoba Oil, Helianthus Annuus (Sunflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Hydrogenated Lecithin, Ubiquinone, Disodium EDTA, Ceramide NP, Sodium Hyaluronate

PURPOSE

OTC - PURPOSE SECTION

Skin Brightening
Anti wrinkle

Uses

INDICATIONS & USAGE SECTION

■ Helps brighten skin tone and improve wrinkles to disappear.
■ Hydrates and calms skin.

WARNINGS

WARNINGS SECTION

For external use only
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Replace the cap after use.
Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

■ After using the BOTA C Ascorbic Acid Ampoule, apply an appropriate amount and gently pat into skin.
■ Increase the effects of vitamin C by frequently reapplying the BOTA C Reset Cream.

Other Information

OTHER SAFETY INFORMATION

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADENOSINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82399-010-022023-01-30C16284748780-1f386c649-b9aa-0266-e053-dadaa90a7c1aa59f6cda-5156-4455-af29-f7c100629a13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82399-010-01BOTA C Reset50 mL in 1 CONTAINERCREAM501
82399-010-02BOTA C Reset1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82399-010BOTA C RESET (NIACINAMIDE, ADENOSINE) CREAM [JB.MONSTER PTY LTD]1Legacy NDC, 2 package rows20211127_a59f6cda-5156-4455-af29-f7c100629a13.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82399-01082399-010-01, 82399-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Niacinamide25X51I8RD4ACTIB
AdenosineK72T3FS567ACTIB
CENTELLA ASIATICA LEAF6810070TYDIACT
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

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
c5e323eb-f593-41fd-842d-47636857ad10a59f6cda-5156-4455-af29-f7c100629a132021-11-26WarningsExact identifier
spl id: c5e323eb-f593-41fd-842d-47636857ad10
spl set id: a59f6cda-5156-4455-af29-f7c100629a13

Reported adverse events (FAERS/openFDA)#

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