COOLING ESSENTIAL OIL- mentholum, camphor oil

Cooling Essential Oil by

Drug Labeling and Warnings

Cooling Essential Oil by is a Otc medication manufactured, distributed, or labeled by Shenzhen E-commerce Trading Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Mentholum 25%, Camphor 20%, Borneol 5%, Menthyl Lactate 5%, Mentha Haplocalyx Oil 2%

PURPOSE

Refresh brain / Relieve dizziness and fatigue / Relieve stuff noses / Mosquito-repellent and relieve itching / Fresh air

WARNINGS

For external use only.

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

If irritation or rash appears and lasts, stop use the product.In case of accidental ingestion, contact a doctor

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Cneter right away.

INSTRUCTIONS FOR USE

Upper layer: Unscrew the upper cap and inhale close to your nose.

Lower layer: Unscrew the lower cap and apply to the skin surface.

INACTIVE INGREDIENT

Isopropyl Myristate, Alcohol, Cymbopogon Citratus Extract, Blumea Balsamifera Oil.

DOSAGE & ADMINISTRATION

Max 4 times on day

INDICATIONS & USAGE

Unscrew the upper cap and inhale close to your nose.

Unscrew the lower cap and apply to the skin surface.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLING ESSENTIAL OIL 
mentholum, camphor oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82421-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHYL LACTATE, (-)-	5 mg  in 100 mL
MENTHA CANADENSIS TOP (UNII: 610T51U707) (MENTHA CANADENSIS TOP - UNII:610T51U707)	MENTHA CANADENSIS TOP	2 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	25 mg  in 100 mL
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)	CAMPHOR OIL	20 mg  in 100 mL
BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X)	BORNEOL	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82421-001-01	2 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/25/2021

Labeler - Shenzhen E-commerce Trading Co., Ltd (699362247)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen E-commerce Trading Co., Ltd		699362247	manufacture(82421-001) , label(82421-001)