MIRACLETOX TIME REWIND ADVANCED FACIAL CLEANSER- witch hazel liquid
Beauren Korea Inc.

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 ingredients: Hamamelis Virginiana (Witch Hazel) Extract 0.09%

INACTIVE INGREDIENT

Inactive ingredients: Water, Decyl Glucoside, Glycerin, Cocamidopropyl Betaine, PEG-120 Methyl Glucose Dioleate, Sodium Cocoyl Apple Amino Acids, Cocamide DEA, 1,2-Hexanediol, Fragrance, Hexylene Glycol, Vitis Vinifera (Grape) Seed Oil, Macadamia Integrifolia Seed Oil, Betaine, Sparassis Crispa Extract, Allantoin, Butylene Glycol, Disodium EDTA, Centella Asiatica Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Lactobacillus/Soybean Ferment Extract, Scutellaria Baicalensis Root Extract, Bletia Hyacinthina Bulb Extract, Coptis Chinensis Root Extract, Rheum Palmatum Root Extract, Phellodendron Amurense Bark Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Do not use on damaged or broken skin. Close the cap after use.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children. Store away from hot or cold places and direct sunlight.

Uses

Uses: Remove waste and makeup on the skin surface without stimulation.

Directions

Directions: Pump Facial Cleanser into wet hands 2-3 times and make bubble enough. Gently massage the skin and cleanse the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MIRACLETOX TIME REWIND ADVANCED FACIAL CLEANSER
witch hazel liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71619-060
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	0.01 g in 15 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71619-060-02	1 in 1 CARTON	08/01/2017	12/31/2020
1	NDC:71619-060-01	15 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/01/2017	12/31/2020

Labeler - Beauren Korea Inc. (689700249)

Registrant - Beauren Korea Inc. (689700249)

Name	Address	ID/FEI	Business Operations
Establishment
Dermafirm INC.		690171603	manufacture(71619-060)

Revised: 12/2020

Document Id: b605f196-afe2-6d83-e053-2a95a90a0584

Set id: 995738a6-7edc-47f0-88fe-bb3db2331ca1

Version: 2

Effective Time: 20201209

Beauren Korea Inc.