XIMONTH AGARWOOD SLEEPING ESSENTIAL OIL- glycerin oil

XIMONTH Agarwood Sleeping Essential Oil by

Drug Labeling and Warnings

XIMONTH Agarwood Sleeping Essential Oil by is a Otc medication manufactured, distributed, or labeled by Guangdong Ouhoe Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

LAVENDER OIL、ROSA X DAMASCENA FLOWER OIL、TOCOPHEROL

PURPOSE

Gentle and comfortable to promote sleep; relax before bedtime; easily help you fall asleep peacefully

USE

Before going to bed, roll the essential oil roller evenly on the body skin and gently massage for 3-5 minutes until absorbed.

WARNINGS

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

STOP USE

Discontinue use if signs of irritation or rash occur.

DO NOT USE

Discontinue use if signs of irritation or rash occur.

KEEP OUT OF REACH OF CHILDREN

Please keep out of reach of children. Do not swallow.

STORAGE AND HANDLING

Store in a cool and dry place.

INACTIVE INGREDIENT

GLYCERIN、ALLANTOIN

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XIMONTH AGARWOOD SLEEPING ESSENTIAL OIL 
glycerin oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84744-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8)	LAVENDER OIL	3 mg  in 10 mg
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) (ROSA X DAMASCENA FLOWER OIL - UNII:18920M3T13)	ROSA X DAMASCENA FLOWER OIL	1 mg  in 10 mg
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8)	TOCOPHEROL	1.5 mg  in 10 mg

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)	3 mg  in 10 mg
GLYCERIN (UNII: PDC6A3C0OX)	1.5 mg  in 10 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84744-065-01	10 mg in 1 BOX; Type 0: Not a Combination Product	10/24/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M014	10/24/2024

Labeler - Guangdong Ouhoe Biotechnology Co., Ltd. (843651433)

Registrant - Guangdong Ouhoe Biotechnology Co., Ltd. (843651433)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Ouhoe Biotechnology Co., Ltd.		843651433	manufacture(84744-065)