Drug Details [pdf]

AAPE CONTINUOUS RENEWAL MASK- witch hazel patch
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, GLYCERIN, BUTYLENE GLYCOL, SORBITOL, HUMAN ADIPOCYTE CONDITIONED MEDIA EXTRACT, GLYCERYL CITRATE, LACTATE, LINOLEATE, OLEATE, OLIVE OIL, POLYSORBATE60, 1,2-HEXANEDIOL, CAPRYLYL GLYOCOL, TROPOLONE, ALCOHOL, METHYLPARABEN, PHENOXYETNANOL, PEG-60 HYDROGENATED CASTOR OIL, ALLANTOIN, MAGMESIUM ASCORBYL PHOSPHATE, TRIETHANOLAMINE, XANTHAN GUM, COLLAGEN, PALMITOYL TRIPEPTIDE-1, CARBOMER, ALOE BARBADENSIS LEAF JUICE POWDER, HYDROXYETHYLCELLULOSE, BIOSACCHARIDE GUM-1, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, CENTELLA ASIATICA EXTRACT, DIPOTASSIUM GLYCYRRHIZATE, PANTHENOL, DISODIUM EDTA, TOCOPHERYL ACETATE, 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. Single use only.
2. Do not put it in extremely hot or cold places or where exposed to direct sunlight.

DOSAGE & ADMINISTRATION

Dosage and Administration:
After cleansing the face, apply gently onto the face, remove the mask after 30-60 minutes as the ingredients in the mask will be fully absorbed. After removing the mask, gently tap and try to absorb into the skin. For the best results, use 1-2 times weekly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AAPE CONTINUOUS RENEWAL MASK
witch hazel patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62041-080
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.15 mg in 10

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62041-080-01	10 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(62041-080)

Revised: 5/2019

Document Id: c1851e8f-57dd-4821-b976-28f3da942861

Set id: 9cd420e7-831a-4d6f-84b3-7abfd51671f5

Version: 3

Effective Time: 20190530

Drug Labeling and Warnings