16BKOUTY LICE TREATMENT liquid

16BKOUTY Lice Treatment by

Drug Labeling and Warnings

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

Drug Details [pdf]

DOSAGE & ADMINISTRATION

After washing your hair, spray an appropriate amount of liquid on the roots of your hair to moisten it

WARNINGS

1. Discontinue use for individuals with skin allergies.

2. Do not use this product when its characteristics have changed.

3. Children must use it under adult supervision.

4. Please keep this product out of reach of children.

INACTIVE INGREDIENT

BENZYL BENZOATE、CHLORHEXIDINE ACETATE、WATER 、ALCOHOL、SOPHORA FLAVESCENS ROOT、DIBUTYL PHTHALATE 、CNIDIUM MONNIERI FRUIT OIL

INDICATIONS & USAGE

STEMONA JAPONICA WHOLE

KEEP OUT OF REACH OF CHILDREN

. Please keep this product out of reach of children.

PURPOSE

Spray on the roots of hair

PRINCIPAL DISPLAY PANEL

84422-102-01

INGREDIENTS AND APPEARANCE

16BKOUTY LICE TREATMENT 
16bkouty lice treatment liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84422-102
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STEMONA SESSILIFOLIA ROOT (UNII: EKG8030U4N) (STEMONA SESSILIFOLIA ROOT - UNII:EKG8030U4N)	STEMONA SESSILIFOLIA ROOT	50 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL BENZOATE (UNII: N863NB338G)
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
DIBUTYL PHTHALATE (UNII: 2286E5R2KE)
CNIDIUM MONNIERI FRUIT OIL (UNII: JK0MS9P8YL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84422-102-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M031	08/05/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Graceful Cosmetics Co., Ltd		449897665	manufacture(84422-102)