Benatu Sleep Essential Oil

Benatu Sleep Essential Oil by

Drug Labeling and Warnings

Benatu Sleep Essential Oil by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BENATU SLEEP ESSENTIAL OIL- sleep aid oil 
GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD.

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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Benatu Sleep Essential Oil

DIPHENHYDRAMINE HYDROCHLORIDE 0.05% v/v

Nighttime Sleep-Aid

Uses

for relief of occasional sleeplessness

Do not use

· for children under 12 years of age

· with any other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

· a breathing problem such as emphysema or chronic bronchitis

· glaucoma

· trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before us if you are taking sedatives or tranquilizers.

When using this product avoid alcoholic drinks.

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years and over:

Take 1-2ml (containing diphenhydramine hydrochloride 50milligrams) at bedtime if needed, or as directed by a doctor.

Other Information

· Store at room temperature, avoid sunlight or high temperature.

· Shelf Life: 3 years

· See the code on the package for the manufacturing date and expiration date

Inactive Ingredients

LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP, SANDALWOOD, STYRAX BENZOIN RESIN, LIME OIL, COLD PRESSED, APRICOT KERNEL OIL, GRAPE SEED OIL

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

NDC: 74935-022-01

NDC: 74935-022-02

NDC: 74935-022-03

NDC: 74935-022-04

BENATU SLEEP ESSENTIAL OIL 
sleep aid oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74935-022
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SANDALWOOD (UNII: 3641YW25N2)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74935-022-01	1 in 1 BOX	07/01/2022
1		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 74935-022-02	3 in 1 BOX	07/01/2022
2		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 74935-022-03	5 in 1 BOX	07/01/2022
3		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 74935-022-04	1 in 1 BOX	07/01/2022
4		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M010	07/01/2022	12/20/2022

Labeler - GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD. (542355899)

Registrant - GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD. (542355899)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD.		542355899	manufacture(74935-022) , label(74935-022) , pack(74935-022)

Revised: 12/2022

Document Id: f05746fd-7f5f-77ac-e053-2a95a90aece8

34390-5

Set id: e5b16fb8-aebc-f3b0-e053-2a95a90a48a0

Version: 4

Effective Time: 20221221

 

GUANGZHOU ORCHAR