MIRACLETOX TIME REWIND BEYOND HOME CARE PROGRAM- niacinamide, adenosine kit

MIRACLETOX Time Rewind Beyond home care program by

Drug Labeling and Warnings

MIRACLETOX Time Rewind Beyond home care program by is a Otc medication manufactured, distributed, or labeled by BEAUREN KOREA INC., Dermafirm INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

niacinamide, adenosine

INACTIVE INGREDIENT

see attached product label

PURPOSE

see attached product label

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

indications are attached in product label

WARNINGS

Use it for your own use only.

For external use only.

Discontinue use if adverse reaction occurs.

Contact a physician if symptoms persist.

Store at room temperature

.Do not reuse it as a disposable product.

Please use it immediately after opening.

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACLETOX TIME REWIND BEYOND HOME CARE PROGRAM 
niacinamide, adenosine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71619-002

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71619-002-01	1 in 1 BOX; Type 0: Not a Combination Product	02/20/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL	2 g
Part 2	1 POUCH	30 g
Part 3	1 BOTTLE	50 g

Part 1 of 3

MIRACLETOX TIME REWIND BEYOND TOX AMPOULE 
niacinamide, adenosine liquid

Product Information
Item Code (Source)	NDC: 71619-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.04 g  in 2 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.0008 g  in 2 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71619-250-02	4 in 1 CARTON
1	NDC: 71619-250-01	2 g in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/20/2020

Part 2 of 3

MIRACLETOX TIME REWIND BEYOND MASK 
niacinamide, adenosine patch

Product Information
Item Code (Source)	NDC: 71619-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.6 g  in 30 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.012 g  in 30 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71619-240-02	4 in 1 CARTON
1	NDC: 71619-240-01	30 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/21/2020

Part 3 of 3

MIRACLETOX TIME REWIND BEYOND FEEL 
niacinamide, adenosine cream

Product Information
Item Code (Source)	NDC: 71619-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	1 g  in 50 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.02 g  in 50 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/20/2020

Labeler - BEAUREN KOREA INC. (689700249)

Registrant - BEAUREN KOREA INC. (689700249)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	manufacture(71619-002)