FDA.reportPublic FDA data

Cellzyme ON-TOX

Manufacturer
PHARMACAL-INTERNATIONAL. CO., LTD
Effective date
2023-02-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:19

Label at a glance#

ProductCellzyme ON-TOX
Active ingredientPEPPERMINT OIL, EUCALYPTUS OIL, FERRIC OXIDE RED
Label structure8 sections

Dosage and administration

Apply small amount and softly tap for absorption.

Label contents#

Full prescribing information#

Actvie Ingrdients

OTC - ACTIVE INGREDIENT SECTION

IRON OXIDES (skin protectant /0.1%) EUCALYPTUS OIL (skin protectant/0.1%) PEPPERMINT OIL (skin protectant/0.1%)

Inactives

INACTIVE INGREDIENT SECTION

WATER, PROPYLENE GLYCOL, HUMAN EMBRYONIC STEM CELL CONDITIONED MEDIA, MAGNESIUM ALUMINIUM SILICATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,HEXANEDIOL, SODIUM SILICATE, SLACTIC ACID, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, XANTHAN GUM, ADENOSINE, DISODIUM EDTA, FRAGRANCE, SALIX ALBA (WILLOW) BARK EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SCUTELLARIA CAICALENSIS ROOT EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, PORTULACA OLERACEA EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, IRON OXIDES(CI77492)

Purpose 

OTC - PURPOSE SECTION

Skin Protectant

Indication and Usage

INDICATIONS & USAGE SECTION

For hiding wrinkle and skin protectant

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply small amount and softly tap for absorption.

Warnings

WARNINGS SECTION

If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms on applied skin under direct sunlight. Do not use on scarred skin, or if you have dermatitis or eczema. Keep away from direct sunlight or heat. Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children 

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDPdrug factsdrug facts

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24765-111-012023-02-03C16284748780-1f386c649-b014-0266-e053-dadaa90a7c1aCellzyme ON-TOX
24765-111-012023-01-30C16284748780-1f386c649-b014-0266-e053-dadaa90a7c1aCellzyme ON-TOX

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24765-11124765-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HEXANEDIOLZIA319275IIACT
SODIUM SILICATEIJF18F77L3IACT
SALICYLIC ACIDO414PZ4LPZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
ADENOSINEK72T3FS567IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SALIX ALBA BARK205MXS71H7IACT
OREGANO0E5AT8T16UIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
CHINESE CINNAMONWS4CQ062KMIACT
SOYBEANL7HT8F1ZODIACT
PURSLANEM6S840WXG5IACT
CHAMAECYPARIS OBTUSA LEAF7OL154J5XBIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
PEPPERMINT OILAV092KU4JHACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
FERRIC OXIDE RED1K09F3G675ACTIB

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
021e18b1-3378-59df-e063-6394a90a73e9bba31087-d72d-4410-a970-c3b47958123c2023-08-04WarningsExact identifier
spl set id: bba31087-d72d-4410-a970-c3b47958123c

Reported adverse events (FAERS/openFDA)#

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