Happy Elf Hemp Pain Relief Cream

Happy Elf Hemp Pain Relief Cream
SPL v2
SPL
SPL Set ID 8169d5dd-9f4a-4044-8156-4712b064f3ef
Route
TOPICAL
Published
Effective Date 2020-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.05 kg) Salicylic Acid (0.075 kg)
Inactive Ingredients
Water Carbomer Homopolymer Type C Dimethyl Sulfone Dimethyl Sulfoxide Glucosamine Glyceryl Stearate Se Polysorbate 80 Cetostearyl Alcohol Arnica Montana Flower Hemp Ethylhexyl Palmitate .alpha.-tocopherol Acetate, Dl- Phenoxyethanol Ethylhexylglycerin Magnesium Hydroxide Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

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


Medication Information

Indications and 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

Description

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

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50567-7

When using this product:

• avoid contact with eyes or mucous membranes

• do not bandage tightly

Section 50569-3

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.

Section 50570-1

Do not use:

• on wounds or damaged skin

• with a heating pad

• on a child under 12 years of age with arthritis-like conditions

Section 51945-4

Warnings:

External Use Only!

Drug Facts

Menthol - 5% (External Analgesic)

Methyl Salicylate (NSAID) – 7.5% (External Analgesic)

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.

For Questions

Call +1 (239) 236-8158

Happy Elf CBD Corporation

2250 NW 102 PL

Miami, FL 33172

Website: www.happyelf.com.com

Allergy Alert:

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

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)

Do not expose to excessive heat

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


Structured Label Content

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

Indications and Usage (34067-9)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

When using this product:

• avoid contact with eyes or mucous membranes

• do not bandage tightly

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

Do not use:

• on wounds or damaged skin

• with a heating pad

• on a child under 12 years of age with arthritis-like conditions

Section 51945-4 (51945-4)

Warnings: (WARNINGS:)

External Use Only!

Drug Facts (DRUG FACTS)

Menthol - 5% (External Analgesic)

Methyl Salicylate (NSAID) – 7.5% (External Analgesic)

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.

For Questions

Call +1 (239) 236-8158

Happy Elf CBD Corporation

2250 NW 102 PL

Miami, FL 33172

Website: www.happyelf.com.com

Allergy Alert:

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

Other Information:

Store at room temperature 68°F to 77°F (20° to 25°C)

Do not expose to excessive heat

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


Advanced Ingredient Data


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