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CELLZYME ON-TOX- oil eucalyptus oil ferric oxide red cream PHARMACAL-INTERNATIONAL. CO., LTD Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ------Cellzyme ON-TOX

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

Inactives 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 () EXTRACT, ORIGANUM VULGARE EXTRACT, SCUTELLARIA CAICALENSIS ROOT EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, PORTULACA OLERACEA EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, IRON OXIDES(CI77492)

Purpose Skin Protectant

Indication and Usage For hiding wrinkle and skin protectant

Dosage and Administration Apply small amount and softly tap for absorption.

Warnings 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

Keep out of reach of children Product Labels CELLZYME ON-TOX peppermint oil eucalyptus oil ferric oxide red cream

Product Information

Product Type HUMAN OTC DRUG Item Code (Source) NDC:24765-111 Route of Administration TOPICAL

Active Ingredient/Active Moiety Basis of Ingredient Name Strength Strength 0.089 g PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL in 100 g 0.092 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL in 100 g FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - 0.084 g FERRIC OXIDE RED UNII:1K09F3G675) in 100 g

Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HEXANEDIOL (UNII: Z IA319275I) SODIUM SILICATE (UNII: IJF18F77L3) (UNII: O414PZ 4LPZ ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) ADENOSINE (UNII: K72T3FS567) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SALIX ALBA BARK (UNII: 205MXS71H7) (UNII: 0E5AT8T16U) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) CHINESE CINNAMON (UNII: WS4CQ062KM) SOYBEAN (UNII: L7HT8F1Z OD) PURSLANE (UNII: M6S840WXG5) CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:24765-111- 5 g in 1 AMPULE; Type 0: Not a Combination 1 09/14/2017 01 Product

Marketing Information Marketing Application Number or Monograph Marketing Start Marketing End Category Citation Date Date OTC monograph not part356 08/16/2017 final

Labeler - PHARMACAL-INTERNATIONAL. CO., LTD (557805060) Revised: 5/2021 PHARMACAL-INTERNATIONAL. CO., LTD