Drug Details [pdf]

AAPE NUTRIENT FACIAL TONER- witch hazel liquid
PROSTEMICS 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: HAMAMELIS VIRGINIANA(WITCH HAZEL) LEAF EXTRACT 0.25%

INACTIVE INGREDIENT

Inactive Ingredient:
WATER, PEG/PPG-17/6CAPRYLYL GLYOCOL COPOLYMER, BUTYLENE GLYCOL, SODIUM HYALURONATE, TREHALOSE, HUMAN ADIPOCYTE CONDITIONED MEDIA EXTRACT, GLYCERYL CITRATE, LACTATE, LINOLEATE, OLEATE, OLIVE OIL, POLYSORBATE60, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, TROPOLONE, PROPYLENE GLYCOL, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, CAPRYLYL GLYOCOL, ETHYLHEXYLGLYCERIN, CELLULOSE GUM, SALIX ALBA(WILLOW) BARK EXTRACT, PANTHENOL, PAEONIA LACTIFLORA ROOT EXTRACT, CONVALLARIA MAJALIS BULB/ROOT EXTRACT, MAGNOLIA LILIFLORA FLOWER EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, LEONTOPODIUM ALPINUM FLOWER/LEAF EXTRACT, TRIETHANOLAMINE, ACRYLATES/C10-30 ALKLY ACRYLATE CROSSPOLYMER, PEG-60 HYDROGENATED CASTOR OIL, GLYCERINE, PALMITOYL TRIPEPTIDE-3, DISODIUM EDTA, 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 cleansing your face, moisten a cotton facial pad with toner.
Move the pad gently in small circles and apply all over the face and neck.
Try to avoid the area around your eyes.
Apply every morning and night.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AAPE NUTRIENT FACIAL TONER
witch hazel liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62041-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.325 mg in 130 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62041-040-01	130 mL in 1 CARTON; Type 0: Not a Combination Product	11/01/2014	03/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/01/2014	03/01/2019

Labeler - PROSTEMICS Co., Ltd. (689605919)

Registrant - PROSTEMICS Co., Ltd. (689605919)

Name	Address	ID/FEI	Business Operations
Establishment
PROSTEMICS Co., Ltd.		689605919	manufacture(62041-040)

Revised: 5/2019

Document Id: ff3be94b-203c-4a4c-b62b-ccb3fe963d3e

Set id: cf8a4bd6-a81d-4e6b-8f6d-047611e37145

Version: 4

Effective Time: 20190530

Drug Labeling and Warnings