PLAGENTRA BABY- glycerin lotion 
C.A Pharm 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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ACTIVE INGREDIENT

Active Ingredient: Glycerin 20%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Hydrogenated Polydecene, Dipropylene Glycol, Macadamia Integrifolia Seed Oil, Butylene Glycol, Cyclohexasiloxane, Betaine, Limnanthes Alba (Meadowfoam) Seed Oil, Stearic Acid, Glyceryl Stearate SE, Cyclopentasiloxane, Dimethiconol, Aloe Barbadensis Leaf Extract, Althaea Rosea Flower Extract, Arctium Lappa Root Extract, Artemisia Capillaris Leaf Extract, Calendula Officinalis Flower Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Ocimum Basilicum (Basil) Leaf Extract, Oenothera Biennis (Evening Primrose) Seed Extract, Perilla Frutescens Leaf Extract, Prunus Mume Fruit Extract, Thymus Vulgaris (Thyme) Extract, 1,2-Hexanediol, Portulaca Oleracea Extract, Hydrolyzed Collagen, Beta-Glucan, Ceramide 3, Raffinose, Palmitoyl Pentapeptide-4, Glyceryl Stearate, Olivoyl Hydrolyzed Wheat Protein, Cetearyl Alcohol, Glyceryl Oleate, Caprylic/Capric Glycerides, Dimethicone, Citrus Paradisi (Grapefruit) Fruit Extract, Polyglutamic Acid, Leuconostoc/Radish Root Ferment Filtrate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Potassium Hydroxide, Disodium EDTA, Xanthan Gum

PURPOSE

Purpose: Skin Portectant

WARNINGS

Warnings:
1. Stop using the product and go to a doctor immediately if one of the following symptoms occurs. If immediate care is not sought, the symptoms may worsen :
1) Itching, redness, swelling, rash, etc. 2) If one of the symptoms above occurs due to direct sunlight.
2. Do not apply the product to wounds or skin with dermatitis such as eczema.
3. Storage and Handling, 1) Keep the lid closed after use. 2) Keep the product out of children's reach. 3) Keep away from direct sunlight, do not store at high or low temperature.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children.

INDICATIONS & USAGE

Indication and usage:
1) Tighten the lid after using it.
2) Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
3) Use it in the morning or evening after shower.

DOSAGE & ADMINISTRATION

Dosage and administration:
Take appropriate amount to the entire face and body, gently massage and tapping until absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PLAGENTRA BABY 
glycerin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68988-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin20 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68988-070-01100 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/01/2014
Labeler - C.A Pharm Co., Ltd. (688198385)
Registrant - C.A Pharm Co., Ltd. (688198385)
Establishment
NameAddressID/FEIBusiness Operations
C.A Pharm Co., Ltd.688198385manufacture(68988-070)

Revised: 12/2014
Document Id: fb018c88-d502-4095-a538-f8084fd67123
Set id: 3cf718cb-535c-4f03-bd47-ea26160f2861
Version: 2
Effective Time: 20141208
 
C.A Pharm Co., Ltd.