hempvana rollerballs (lidocaine)

hempvana rollerballs (lidocaine)
SPL v2
SPL
SPL Set ID d91ba9b1-083f-32e9-e053-2a95a90a9bd1
Route
topical
Published
Effective Date 2022-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g)
Inactive Ingredients
ethylhexylglycerin polysorbate 60 glycerin fd&c yellow no. 5 water dihexadecyl phosphate hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) carbomer interpolymer type a (allyl sucrose crosslinked) edetate disodium anhydrous dimethicone glyceryl monostearate alcohol .alpha.-tocopherol acetate c30-45 alkyl cetearyl dimethicone crosspolymer aminomethylpropanol fd&c blue no. 1 cannabis sativa seed oil ceteth-20 phosphate squalane cetostearyl alcohol phenoxyethanol caprylyl trisiloxane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-02-28

Purpose

Lidocaine 4%....................Topical Analgesic

Description

Lidocaine 4%


Medication Information

Warnings

For external use only

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

Uses

For the temporary relief of pain

Purpose

Lidocaine 4%....................Topical Analgesic

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
Inactive Ingredients

Water/Aqua/Eau, Alcohol Denat., Glycerin, Dimethicone, Glyceryl Stearate, Caprylyl Methicone, Cannabis Sativa (Hemp) Seed Oil, Ceteth-20 Phosphate, Cetearyl Alcohol, Squalane, Tocopheryl Acetate, Phenoxyethanol, C30-45 Alkyl Cetearyl, Dimethicone Crosspolymer, Dicetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Polysorbate 60, Disodium EDTA, Aminomethyl Propanol, Yellow 5 (CI 19140), Blue 1 (CI 42090)

Description

Lidocaine 4%

Questions?

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

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

Odor Free!

New! 5 Deep Massaging Stainless Steel Rollerballs

With 4% Lidocaine For Pain

+Hemp Seed Oil For Moisturization

Net Wt. 2.5 OZ (71 g)

Section 53414-9

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

Active Ingredient

Lidocaine 4%


Structured Label Content

Warnings

For external use only

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

Uses

For the temporary relief of pain

Purpose

Lidocaine 4%....................Topical Analgesic

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
Inactive Ingredients

Water/Aqua/Eau, Alcohol Denat., Glycerin, Dimethicone, Glyceryl Stearate, Caprylyl Methicone, Cannabis Sativa (Hemp) Seed Oil, Ceteth-20 Phosphate, Cetearyl Alcohol, Squalane, Tocopheryl Acetate, Phenoxyethanol, C30-45 Alkyl Cetearyl, Dimethicone Crosspolymer, Dicetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Polysorbate 60, Disodium EDTA, Aminomethyl Propanol, Yellow 5 (CI 19140), Blue 1 (CI 42090)

Questions?

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

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

Odor Free!

New! 5 Deep Massaging Stainless Steel Rollerballs

With 4% Lidocaine For Pain

+Hemp Seed Oil For Moisturization

Net Wt. 2.5 OZ (71 g)

Section 53414-9 (53414-9)

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

Active Ingredient

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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