FDA.reportPublic FDA data

Happy Elf CBD Pain Relief Cream

Manufacturer
Happy Elf CBD Corporation | Cosco International, Inc
Effective date
2020-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:28

Label at a glance#

ProductHappy Elf CBD Pain Relief Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

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

Uses:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

External Use Only!

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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.

OTC - WHEN USING SECTION

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

INDICATIONS & USAGE SECTION

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: 

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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

Other Information:

SPL UNCLASSIFIED SECTION

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

Allergy Alert:

SPL UNCLASSIFIED SECTION

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

For Questions

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CBD Pain Cream Tube LabelCBD Pain Cream Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CBD Pain Cream Box LabelCBD Pain Cream Box Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73658-3400-12023-01-30C16284748780-1f386c649-ad8d-0266-e053-dadaa90a7c1aHappy Elf CBD Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73658-3400-0Happy Elf CBD Pain Relief Cream0.114 kg in 1 TUBECREAM0.1141
73658-3400-1Happy Elf CBD Pain Relief Cream1 in 1 PACKAGECREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73658-3400HAPPY ELF CBD PAIN RELIEF CREAM (MENTHOL, METHYL SALICYLATE) CREAM [HAPPY ELF CBD CORPORATION]1Legacy NDC, 2 package rows20200401_40e61bd9-8cf1-420c-9abb-2b2fc7dd650d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73658-340073658-3400-0, 73658-3400-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
GLUCOSAMINEN08U5BOQ1KIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
POLYSORBATE 806OZP39ZG8HIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CANNABIS SATIVA WHOLEB5ONF538PBIACT
ETHYLHEXYL PALMITATE2865993309IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3b21aea0-8a68-4f6e-aa62-8aa6eb1ab58040e61bd9-8cf1-420c-9abb-2b2fc7dd650d2020-03-19WarningsExact identifier
spl id: 3b21aea0-8a68-4f6e-aa62-8aa6eb1ab580
spl set id: 40e61bd9-8cf1-420c-9abb-2b2fc7dd650d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.