MYCELLCARE- glycerin cream

myCellCare by

Drug Labeling and Warnings

myCellCare by is a Otc medication manufactured, distributed, or labeled by Pharmacal-International. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin 3.50%

PURPOSE

Skin protectant

INDICATIONS & USAGE

Relieves vaginal itch, burning and discharge

DOSAGE & ADMINISTRATION

Apply liberally as needed, softly massage for absorption

WARNINGS

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash, swelling, or irritation occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Butylene Glycol, Human Stem Cell Conditioned Media, 1,2-Hexanediol, Lactic Acid, Hydroxyethylcellulose, Sodium Lactate, Peg-60 Hydrogenated Castor Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Chlorphenesin, Fragrance, L-Arginine, Allantoin, Xanthan Gum, Disodium Edta, Citric Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Rosa Centifolia Flower Water, Eucalyptus Globulus Leaf Extract, Aspalathus Linearis Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Aloe Barbadensis Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Extract, Lavandula Angustifolia (Lavender) Flower Extract, Ehtylhexylglycerin, Acetyl Hexapeptide-8

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYCELLCARE 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.175 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
CHLORPHENESIN (UNII: I670DAL4SZ)
ARGININE (UNII: 94ZLA3W45F)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
JOJOBA OIL (UNII: 724GKU717M)
SQUALANE (UNII: GW89575KF9)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSEMARY (UNII: IJ67X351P9)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-105-02	8 in 1 BOX	10/07/2016
1	NDC: 24765-105-01	5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/07/2016

Labeler - Pharmacal-International. Co., Ltd. (557805060)

Registrant - Pharmacal-International. Co., Ltd. (557805060)

Establishment
Name	Address	ID/FEI	Business Operations
Greencos Co., Ltd.		694777325	manufacture(24765-105)