HAPPY ELF HEMP PAIN RELIEF CREAM- menthol, methyl salicylate cream

Happy Elf Hemp Pain Relief Cream by

Drug Labeling and Warnings

Happy Elf Hemp Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Happy Elf CBD Corporation, Cosco International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Menthol - 5% (External Analgesic)
Methyl Salicylate (NSAID) – 7.5% (External Analgesic)

Uses:

For temporary relief of minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation

WARNINGS:

External Use Only!

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.

DO NOT USE

Do not use:
on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions

ASK DOCTOR

Ask a doctor before use if you have redness over the affected area.

If pregnant or breast-feeding, or if you have sensitive skin, ask your doctor before use

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

WHEN USING

When using this product:
avoid contact with eyes or mucous membranes
do not bandage tightly

INDICATIONS & USAGE

Stop use and ask a doctor if: condition worsens or symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, excessive skin irritation occurs

Directions:

Use only as directed. Apply generously and massage to affected area as needed. Do not use more than 3 to 4 times per day.
Children under 12 years of age: ask a doctor before use.

Inactive Ingredients:

Alpha-Tocopherol Acetate (Vitamin E), Aminomethylpropanol, Arnica Montana Flower, Hemp Oil, Carbomer, Cetostearyl Alcohol, Dimethyl Sulfone, Dimethyl Sulfoxide, Ethylhexyl Palmitate, Ethylhexylglycerin, Glucosamine, Glyceryl Monostearate, Magnesium Hydroxide, Phenoxyethanol, Polysorbate 80, Water

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat

Allergy Alert:

Do not use if you are allergic to salicylates (including aspirin) without consulting a physician.

For Questions

Call +1 (239) 236-8158
Happy Elf CBD Corporation
2250 NW 102 PL
Miami, FL 33172
Website: www.happyelf.com.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAPPY ELF HEMP PAIN RELIEF CREAM 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73658-3401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.05 kg  in 1 kg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.075 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
GLUCOSAMINE (UNII: N08U5BOQ1K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
HEMP (UNII: TD1MUT01Q7)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73658-3401-1	1 in 1 CARTON	03/30/2020
1	NDC: 73658-3401-0	0.114 kg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2020

Labeler - Happy Elf CBD Corporation (117409880)

Registrant - Happy Elf CBD Corporation (117409880)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc		016433141	manufacture(73658-3401) , relabel(73658-3401) , pack(73658-3401)