ULTRA REJUVE 7S AMPOULE- glycerin liquid 
ULAB

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 0.97%

INACTIVE INGREDIENT

Inactive ingredients: AQUA (WATER), PROPYLENE GLYCOL, PANTHENOL, PENTYLENE GLYCOL, PHENOXYETHANOL, HYDROLYZED WHEAT PROTEIN, CAPRYLYL/CAPRYL GLUCOSIDE, CENTELLA ASIATICA EXTRACT, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PARFUM (FRAGRANCE), SACCHAROMYCES LYSATE, DISODIUM EDTA, TRITICUM VULGARE (WHEAT) SEED EXTRACT, ALGAE EXTRACT, SODIUM HYDROXIDE, o-CYMEN-5-OL, ETHYLHEXYLGLYCERIN, DISODIUM SUCCINATE, GLUTAMIC ACID, GLYCINE, THREONINE, VALINE, CITRIC ACID, POTASSIUM SORBATE, SODIUM BENZOATE, CI 19140 (FD&C YELLOW N°5)

PURPOSE

Purpose: Skin rebalancing and nourishing

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Apply morning and night

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply morning and night on clean face and neck prior to moisturizers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ULTRA REJUVE 7S AMPOULE 
glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.04 g  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71276-120-025 in 1 CARTON03/02/2017
1NDC:71276-120-015 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/02/2017
Labeler - ULAB (688976692)
Registrant - ULAB (688976692)
Establishment
NameAddressID/FEIBusiness Operations
ULAB688976692relabel(71276-120)
Establishment
NameAddressID/FEIBusiness Operations
U-LAB Switzerland AG485958743manufacture(71276-120)

Revised: 3/2017
Document Id: ba2089ba-60d7-4b38-8792-abcc76c65337
Set id: 643f64bd-0b9d-43e5-95e4-0208a192c093
Version: 1
Effective Time: 20170322
 
ULAB