16BKOUTY NALL FUNGUS RENEWAL liquid

16BKOUTY NALL FUNGUS RENEWAL by

Drug Labeling and Warnings

16BKOUTY NALL FUNGUS RENEWAL by is a Otc medication manufactured, distributed, or labeled by Shenzhen Graceful Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

If you experience any discomfort, please stop using and seek medical attention promptly

CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

DOSAGE & ADMINISTRATION

【 Instructions 】 Take an appropriate amount of this product and apply it to the surface of the skin.Once in the morning and once in the evening.

INACTIVE INGREDIENT

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PURPOSE

This product is used for skin antibacterial purposes

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

16BKOUTY NALL FUNGUS RENEWAL 
16bkouty nall fungus renewal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84422-101
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHELLODENDRINE (UNII: AR68S526RB) (PHELLODENDRINE - UNII:AR68S526RB)	PHELLODENDRINE	1 g  in 100 mL
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)
CAMPHOR OIL (UNII: 75IZZ8Y727)
ACETIC ACID (UNII: Q40Q9N063P)
SILVER CATION (UNII: 57N7B0K90A)
PROTOSTEPHANINE (UNII: 8HEL0402TN)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
AINSLIAEA FRAGRANS WHOLE (UNII: 5FG998PBC2)
PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)	0.2 g  in 100 mL
LEONURINE (UNII: 09Q5W34QDA)
GLYCERIN (UNII: PDC6A3C0OX)
COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)
BORNEOL (UNII: M89NIB437X)
OLIVE OIL (UNII: 6UYK2W1W1E)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CROCUS SATIVUS FLOWER (UNII: 00IF91KFKQ)
IMPATIENS BALSAMINA FLOWER (UNII: 3169PS5TJH)
SMILACIN (UNII: 7913T95W7U)
PURSLANE (UNII: M6S840WXG5)
CYRTOMIUM FORTUNEI WHOLE (UNII: KVO7W5ZIG8)
EUCALYPTUS SMITHII OIL (UNII: X4023CB3OK)
ALOE FEROX LEAF (UNII: 0D145J8EME)
STEPHANIA JAPONICA WHOLE (UNII: 9R6ON4417X)
GLEDITSIA SINENSIS THORN (UNII: 26LKE578NY)
ISATIDINE (UNII: 51819GRV4U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84422-101-01	30 mL in 1 BOTTLE; Type 6: Drug/Biologic Combination	06/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/25/2024

Labeler - Shenzhen Graceful Cosmetics Co., Ltd (449897665)

Registrant - Shenzhen Graceful Cosmetics Co., Ltd (449897665)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Graceful Cosmetics Co., Ltd		449897665	manufacture(84422-101) , label(84422-101)