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.

BENATU SLEEP ESSENTIAL OIL 
sleep aid oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74935-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74935-022-011 in 1 BOX07/01/2022
110 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 74935-022-023 in 1 BOX07/01/2022
210 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 74935-022-035 in 1 BOX07/01/2022
310 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 74935-022-041 in 1 BOX07/01/2022
430 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01007/01/202212/20/2022
Labeler - GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD. (542355899)
Registrant - GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD. (542355899)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO., LTD.542355899manufacture(74935-022) , label(74935-022) , pack(74935-022)

Revised: 12/2022
 
GUANGZHOU ORCHAR

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