AT ALPHA- glycerin cream 
SALOJE 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 Ingredient: Glycerin 10.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Caprylic/Capric Triglyceride, Betaine, Cetearyl Alcohol, Butylene Glycol Dicaprylate/Dicaprate, Squalane, Sorbitan Stearate, Stearic Acid, Polyglyceryl-10 Distearate, Glyceryl Stearate, Dimethicone, Sodium Hyaluronate, Aureobasidium Pullulans Ferment Filtrate, Tocopheryl Acetate, Portulaca Oleracea Extract, Aloe Barbadensis Leaf Juice, Rehmannia Chinensis Root Extract, Schizonepeta Tenuifolia Extract, Saururus Chinensis Leaf/Root Extract, Polygonum Fagopyrum (Buckwheat) Seed Extract, Glycine Max (Soybean) Seed Extract, Acanthopanax Senticosus (Eleuthero) Root Extract, Ulmus Davidiana Root Extract, Poria Cocos Extract, Ginkgo Biloba Leaf Extract, Prunus Armeniaca (Apricot) Kernel Extract, Sanguisorba Officinalis Root Extract, Phellodendron Amurense Bark Extract, Prunus Mume Fruit Extract, Zanthoxylum Piperitum Fruit Extract, Pinus Densiflora Extract, Magnolia Obovata Bark Extract, Polygonum Cuspidatum Root Extract, Sophora Angustifolia Root Extract, Camellia Sinensis Leaf Extract, Ganoderma Lucidum (Mushroom) Stem Extract, Carthamus Tinctorius (Safflower) Flower Extract, Oryza Sativa (Rice) Bran Extract, Bletia Hyacinthina Bulb Extract, Allantoin, 1,2-Hexanediol, Propanediol, Caprylyl Glycol, Illicium Verum (Anise) Fruit Extract, Arginine, Carbomer, Alloferon-1

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. Do not use if irritation occurs. 2. Avoid using on sensitive skin. 3. For external use only. 4. Store in a cool place

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indications & usage: After washing the face, dispense an appropriate amount into your palm, and evenly apply to the entire face.

DOSAGE & ADMINISTRATION

Dosage & Administration: Spread an appropriate amount over the entire face following the skin texture.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AT ALPHA 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70141-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin5 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70141-010-0150 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2015
Labeler - SALOJE Inc (689516928)
Registrant - SALOJE Inc (689516928)
Establishment
NameAddressID/FEIBusiness Operations
SALOJE Inc689516928manufacture(70141-010)

Revised: 10/2015
Document Id: b6a1fcd9-6d25-49d8-9cc4-97720d742b2b
Set id: 3923dfce-23ba-46d2-95ce-6c35b7f7e6bc
Version: 1
Effective Time: 20151006
 
SALOJE Inc