CELLZYME SECRET THERAPY 3845- glycerine, eucalyptusoil, allantoin 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 Secret Therapy 3845

Actvie Ingrdients

GLYCERIN (Skin protectant /4%) ALLANTOIN (Skin protectant/0.1%) CELLULOSE (Skin protectant /0.001%)

Inactives

WATER, HUMAN STEM CELL CONDITIONED MEDIA, BUTYLENE GLYCOL, 1,2-HEXANEDIOL, ARGININE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATECOPOLYMER, LACTIC ACID, SODIUM LACTATE, PEG-60 HYDROGENATED CASTOR OIL, CHLORPHENESIN, XANTHAN GUM, CITRIC ACID, SQUALANE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, PROPANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED COLLAGEN, MENTHA PIPERITA (PEPPERMINT) EXTRACT, PISUM SATIVUM (PEA) PEPTIDE, PALMITOYL TRIPEPTIDE-5, COPPER TRIPEPTIDE-1, SH-OLIGOPEPTIDE-1, PHOENIX DACTYLIFERA (DATE) FRUIT EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, OPUNTIA FICUS-INDICA EXTRACT, ADANSONIA DIGITATA SEED EXTRACT, CENTELLA ASIATICA EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ARTEMISIA MONTANA LEAF EXTRACT, VACCINIUM CORYMBOSUM (BLUEBERRY) FRUIT EXTRACT, GINKGO BILOBA LEAF EXTRACT, ROSA CANINA FRUIT OIL, CELLULOSE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, FRAGRANCE

Purpose

Skin Protectant

Indication and Usage

Relieves vaginal itch, burning and discharge.

Dosage and Administration

Apply liberally as needed, softly massage 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. Keep away from direct sunlight or heat. Keep out of reach of children. Follow the directions. Do not use during the pregnancy.

Keep out of reach of children

Product Labels

Drug facts PDP

CELLZYME SECRET THERAPY 3845
glycerine, eucalyptusoil, allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24765-117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	5.2 g in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.145 g in 100 mL
POWDERED CELLULOSE (UNII: SMD1X3XO9M) (POWDERED CELLULOSE - UNII:SMD1X3XO9M)	POWDERED CELLULOSE	0.0015 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ARGININE (UNII: 94ZLA3W45F)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SQUALANE (UNII: GW89575KF9)
JOJOBA OIL (UNII: 724GKU717M)
PROPANEDIOL (UNII: 5965N8W85T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
PEA (UNII: W4X7H8GYFM)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
NEPIDERMIN (UNII: TZK30RF92W)
DATE (UNII: H3O7QI5HY7)
FIG (UNII: TGD87RII2U)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ARTEMISIA MONTANA LEAF (UNII: 1548S9624V)
HIGHBUSH BLUEBERRY (UNII: DVH063L9QI)
GINKGO (UNII: 19FUJ2C58T)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24765-117-01	3 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2017	07/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/16/2017	07/31/2023

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

Name	Address	ID/FEI	Business Operations
Establishment
EcoWorldpharm Co., Ltd.		688735061	manufacture(24765-117)

Revised: 8/2023

Document Id: 021e2cdc-3a92-5dd5-e063-6394a90aa555

Set id: 300db83a-ecc3-4e0a-a93c-51de4d381475

Version: 4

Effective Time: 20230804

PHARMACAL-INTERNATIONAL. CO., LTD