Drug Details [pdf]

AAPE CONTINUOUS RENEWAL- 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.

----------

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, OLEA EUROPAEA (OLIVE) FRUIT OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, CETYL ETHYLHEXANOATE, CYCLOPENTASILOXANE, NIACINAMIDE, OCTYLDODECYL MYRISTATE, PEG-100 STEARATE, CETEARYL ALCOHOL, SODIUM HYALURONATE, BEESWAX, DIISOSTEARYL MALATE, CYCLOPENTASILOXANE, DIMETHICONE/VINYL DIMETHICONE CROSS POLYMER, PAEONIA LACTIFLORA ROOT EXTRACT, CONVALLARIA MAJALIS BULB/ROOT EXTRACT, MAGNOLIA LILIFLORA FLOWER EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, LEONTOPODIUM ALPINUM FLOWER/LEAF EXTRACT, PROPYLENE GLYCOL, HYDROLYZED EXTENSIN, ETHYLHEXYLGLYCERIN, HYDROGENATED VEGETABLE OIL, BETA-GLUCAN, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, COPPER TRIPEPTIDE-1, BUTYROSPERMUM PARKII(SHEA BUTTER), STEARIC ACID, ACETYL HEXAPEPTIDE-8, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, PEG-40 STEARATE, DIMETHICONE, GLYCERYL STEARATE, CARBOMER, POTASSIUM HYDROXIDE, 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 use of serum, take appropriate amount of the cream with your fingertips and apply the cream evenly and massage it very lightly all over the face and neck, avoiding the eye area. Apply every morning and night.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AAPE CONTINUOUS RENEWAL
witch hazel cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62041-070
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.25 mg in 50 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: 62041-070-01	50 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(62041-070)

Revised: 5/2019

Document Id: d6ddd327-ca27-4be5-ae5a-d95ca8cff128

Set id: 1be062ea-5971-41af-a864-62245784cd85

Version: 3

Effective Time: 20190530

Drug Labeling and Warnings