ULTRA REJUVE 7S AMPOULE: Package Insert and Label Information

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.

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

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ULTRA REJUVE 7S AMPOULE
glycerin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71276-120
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 0.04 g in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71276-120-02 5 VIAL in 1 CARTON contains a VIAL (71276-120-01)
1 NDC:71276-120-01 5 mL in 1 VIAL This package is contained within the CARTON (71276-120-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/02/2017
Labeler — ULAB (688976692)
Registrant — ULAB (688976692)
Establishment
Name Address ID/FEI Operations
ULAB 688976692 relabel (71276-120)
Establishment
Name Address ID/FEI Operations
U-LAB Switzerland AG 485958743 manufacture (71276-120)

Revised: 03/2017 ULAB

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