Drug Details [pdf]

AAPE CONTINUOUS RENEWAL SERUM- witch hazel cream
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 0.50%

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, GLYCERIN, PEG/PPG-17/6 COPOLYMER, SODIUM HYALURONATE, NIACINAMIDE, PHENYL TRIMETHICONE, BIOSACCHARIDE GUM-1, ACETYL HEXAPEPTIDE-8 , PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, BETULA PLATYPHYLLA JAPONICA JUICE, ETHYLHEXYLGLYCERIN, TREHALOSE, PORTULACA OLERACEA EXTRACT, BETA-GLUCAN, PROPYLENE GLYCOL, HYDROLYZED EXTENSIN, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, XANTHAN GUM, ARNICA MONTANA FLOWER EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, GENTIANA LUTEA ROOT EXTRACT, ALCOHOL, POTASSIUM SORBATE, PHENOXYETHANOL, COPPER TRIPEPTIDE-1, PEG-60 HYDROGENATED CASTOR OIL, CARBOMER, POTASSIUM HYDROXIDE, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, CELLULOSE GUM, 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:
Use about a pea-sized amount of serum, apply the serum and pat gently about two minutes all over your face and neck. Apply every morning and night.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AAPE CONTINUOUS RENEWAL SERUM
witch hazel cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62041-050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.2 mg in 40 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
OLIVE OIL (UNII: 6UYK2W1W1E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62041-050-01	40 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(62041-050)

Revised: 5/2019

Document Id: 6b03c530-7c82-44b3-ab7b-137e47c684fe

Set id: c38c6d63-cbe6-4833-b41f-1a05fda81d79

Version: 3

Effective Time: 20190530

Drug Labeling and Warnings