Hempvana Rollerballs (arthritis)

Hempvana Rollerballs (arthritis)
SPL v2
SPL
SPL Set ID d91b2e09-550e-4968-e053-2995a90ae323
Route
TOPICAL
Published
Effective Date 2022-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8 g)
Inactive Ingredients
Arnica Montana Flower Camphor (natural) Alcohol Water Phenoxyethanol Glycerin Carbomer Homopolymer, Unspecified Type Edetate Disodium Anhydrous Silicon Dioxide Sodium Hydroxide Ethylhexylglycerin .alpha.-tocopherol Acetate Fd&c Yellow No. 5 Fd&c Blue No. 1 Isopropyl Myristate Cannabis Sativa Seed Oil Aloe Vera Leaf Arctium Lappa Root Green Tea Leaf Melissa Officinalis Turmeric Calendula Officinalis Flower Ilex Paraguariensis Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-28

Description

Menthol 8%

Purpose

Menthol 8%....................Topical Analgesic


Medication Information

Purpose

Menthol 8%....................Topical Analgesic

Description

Menthol 8%

Uses

For the temporary relief of pain

Section 50565-1

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present or irritation develops
Section 50567-7

When using this product

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not use at the same time as other topical analgesics.
Section 51945-4

#1 Hemp Pain Relief Brand in America 1

1AC Nielsen 2021 food drug mass POS

Hempvana Brand

Ultra Strength Pain Relief Lotion

NEW! 5 Deep Massaging Stainless Steel Rollerballs

Arthritis

+ Hemp Seed Oil For Moisturization

Menthol 8% For Pain

Net Wt. 2.5 OZ (71g)

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Directions
  • Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily using roller ball applicator
  • Children under 2 years of age:consult a physician
Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

Active Ingredient

Menthol 8%

Inactive Ingredients

Water/Aqua/Eau, Alcohol Denat., Isopropyl Myristate, Cannabis Sativa (Hemp) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Arnica Montana Flower Extract,, Melissa Officinalis (Balm Mint) Extract, Camphor, Phenoxyethanol, Glycerin, Carbomer, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA, Tocopheryl Acetate, Silica, Yellow 5 (CI 19140), Blue 1 (CI 42090)


Structured Label Content

Uses

For the temporary relief of pain

Section 50565-1 (50565-1)

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present or irritation develops
Section 50567-7 (50567-7)

When using this product

  • Use only as directed. Read and follow all directions and warnings on this label.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged, broken or irritated skin.
  • Do not use at the same time as other topical analgesics.
Section 51945-4 (51945-4)

#1 Hemp Pain Relief Brand in America 1

1AC Nielsen 2021 food drug mass POS

Hempvana Brand

Ultra Strength Pain Relief Lotion

NEW! 5 Deep Massaging Stainless Steel Rollerballs

Arthritis

+ Hemp Seed Oil For Moisturization

Menthol 8% For Pain

Net Wt. 2.5 OZ (71g)

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Menthol 8%....................Topical Analgesic

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Directions
  • Adults and children 2 years of age and older:apply to affected area not more than 3 to 4 times daily using roller ball applicator
  • Children under 2 years of age:consult a physician
Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

Active Ingredient

Menthol 8%

Inactive Ingredients

Water/Aqua/Eau, Alcohol Denat., Isopropyl Myristate, Cannabis Sativa (Hemp) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Arnica Montana Flower Extract,, Melissa Officinalis (Balm Mint) Extract, Camphor, Phenoxyethanol, Glycerin, Carbomer, Ethylhexylglycerin, Sodium Hydroxide, Disodium EDTA, Tocopheryl Acetate, Silica, Yellow 5 (CI 19140), Blue 1 (CI 42090)


Advanced Ingredient Data


Raw Label Data

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