JENACELL SUPERCELL SERUM- glycerin, allantoin, hydroxyethyl cellulose liquid 
Functionfive Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active ingredients: Glycerin 7%, Allantion 0.3%, Hydroxyethyl cellulose 0.9%

INACTIVE INGREDIENT

Inactive ingredients: Di-Water, Butylene Glycol,water, Coptis Chinensis Root Extract, Pentylene Glycol,Usnea Barbata (Lichen) Extract, Zanthoxylum Schinifolium Leaf Extract, Pulsatilla Koreana Extract), Arginine, Alanine, Tyrosine, Histidine, Leucine, Methionine, Citrus Paradisi (Grapefruit) Seed Oil, Hydroxyethylcellulose, PEG-60 Hydrogenated Castor Oil, Tocopheryl Acetate,Allantoin, LacTic Acid, Caesalpinia Spinosa Gum, Centella Asiatica Extract,Dipotassium Glycyrrhizate, Hydrogenated Polyisobutene and Anemarrhena Asphodeloides Root Extract., Lavandula Angustifolia (Lavender) Oil, Panax Ginseng Callus Culture Extract, Pelargonium Graveolens Oil, Rosa Damascena flower Oil, Solanum Lycopersicum (Tomato) Callus Culture Extract, Disodium EDTA, Vanillyl Butyl Ether.

PURPOSE

Purpose: Sanitizer, Skin protectant, Moisturizing

WARNINGS

Warnings:

For external use only 1. Vulvar Cleanser (a) It should only be used on the vulva. (b) It should not be used for long periods of time. (c) It should be used with extreme caution when there are affected areas on the (vulvar) skin or the surrounding area has become contaminated. (d) It should not be used on children under 3 years of age. (e) It is not recommended for use during pregnancy and it is advised that you discontinue its use on the vulva until you deliver a baby as it may get into the eyes of the newborn baby.

2. KEEP OUT OF REACH OF CHILDREN Keep this product out of reach of infants and young children.

3. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

4. Do not apply to wounds and the area affected by dermatitis, eczema, and other irritations.

KEEP OUT OF REACH OF CHILDREN

Keep this product out of reach of infants and young children.

INDICATIONS & USAGE

INDICATIONS & USAGE:

1. Please discontinue use immediately in the event that you experience any of the following side effects from using this product, and consult a dermatologist as the symptoms may get worse with continued use. (a) Adverse skin reactions occur upon its application which may involve red spots, swelling, itchiness, and other skin irritation. (b) The applied part shows signs of any of the symptoms mentioned above after exposure to the direct sunlight.

2. Precautions for handling and storage (a) Always throw away after each use. (b) Always keep the product out of the reach of infants. (c) Do not store the product in high and low temperatures. It should also be kept out of direct sunlight.

Apply liberally as needed softly massage for absorption to your vulva area. Apply a suitable amount evenly to the region and massage gently.

DOSAGE & ADMINISTRATION

Directions: The applicator designed by disposable. After using always throw away the applicator.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

JENACELL SUPERCELL SERUM 
glycerin, allantoin, hydroxyethyl cellulose liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71339-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.14 g  in 2 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.006 g  in 2 mL
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) (HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) - UNII:R33S7TK2EP) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)0.018 g  in 2 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71339-010-028 in 1 CARTON03/01/201711/01/2019
1NDC:71339-010-012 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/201711/01/2019
Labeler - Functionfive Inc. (694768576)
Registrant - Functionfive Inc. (694768576)
Establishment
NameAddressID/FEIBusiness Operations
HANIL PHARMACEUTICAL CO., LTD.688197087manufacture(71339-010)

Revised: 12/2019
 
Functionfive Inc.