CELLZYME ON-TOX- peppermint 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.

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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 (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

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

PDP drug facts

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

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HEXANEDIOL (UNII: ZIA319275I)
SODIUM SILICATE (UNII: IJF18F77L3)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SALIX ALBA BARK (UNII: 205MXS71H7)
OREGANO (UNII: 0E5AT8T16U)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
CHINESE CINNAMON (UNII: WS4CQ062KM)
SOYBEAN (UNII: L7HT8F1ZOD)
PURSLANE (UNII: M6S840WXG5)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

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

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

Labeler - PHARMACAL-INTERNATIONAL. CO., LTD (557805060)