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AAPE Continuous Renewal Eye

Medically reviewed on December 11, 2017

Dosage form: cream
Ingredients: WITCH HAZEL 0.1mg in 20mL
Labeler: Prostemics Co., Ltd.
NDC Code: 62041-060

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.

ACTIVE INGREDIENT

Active Ingredient: HAMAMELIS VIRGINIANA(WITCH HAZEL) LEAF EXTRACT 0.50%

INACTIVE INGREDIENT

Inactive Ingredient:
WATER, HUMAN ADIPOCYTE CONDITIONED MEDIA EXTRACT, GLYCERYL CITRATE, LACTATE, LINOLEATE, OLEATE, OLIVE OIL, POLYSORBATE60, 1,2-HEXANEDIOL, CAPRYLYL GLYOCOL, TROPOLONE, BUTYLENE GLYCOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, GLYCERIN, SODIUM HYALURONATE, NIACINAMIDE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ACETYL HEXAPEPTIDE-8, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, GLYCERYL STEARATE, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, ALCOHOL, , PROPYLENE GLYCOL, HYDROLYZED EXTENSINPOTASSIUM SORBATE, PROPYLENE GLYCOL, PHENOXYETHANOL, COPPER TRIPEPTIDE-1, CETEARYL ALCOHOL, ETHYLHEXYLGLYCERIN, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, BEESWAX, CETEARYL OLIVATE, SORBITAN OLIVATE, DIMETHICONE, ADENOSINE, FRAGRANCE

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:
1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist.
1) In case of having problems such as red spots, swelling, itching or irritation during using this product,
2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight.
2. Do not use it on the part where you have a scar, eczema or dermatitis.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of infants or children's reach.

INDICATIONS & USAGE

Indication and Usage:
1. Always keep a tight lid after use.
2. Do not put it in extremely hot or cold places or where exposed to direct sunlight.

DOSAGE & ADMINISTRATION

Dosage and Administration:
After cleaning and toning take out a small amount, apply the eye cream along the length of the top eyelid and gently dot the cream around your eye area. Apply every night.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AAPE CONTINUOUS RENEWAL EYE 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL0.1 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
OLIVE OIL 
Packaging
#Item CodePackage Description
1NDC:62041-060-0120 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2014
Labeler - Prostemics Co., Ltd. (687768142)
Registrant - Prostemics Co., Ltd. (687768142)
Establishment
NameAddressID/FEIOperations
Prostemics Co., Ltd.687768142manufacture(62041-060)

 
Prostemics Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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