Mycellcare (Glycerin) Cream [Pharmacal-International. Co., Ltd.] -

MYCELLCARE (GLYCERIN) CREAM [PHARMACAL-INTERNATIONAL. CO., LTD.]
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NDC	24765-105-01, 24765-105-02
Set ID	ee837568-8d20-4fae-baec-a467df286ffc
Category	HUMAN OTC DRUG LABEL
Packager	Pharmacal-International. Co., Ltd.
Generic Name
Product Class
Product Number
Application Number

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/07/2016

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

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

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