Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine

Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine
SPL v1
SPL
SPL Set ID 2788189e-35bc-d48c-e063-6294a90ae6c2
Route
TOPICAL
Published
Effective Date 2024-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Fd&c Yellow No. 5 Fd&c Blue No. 1 Glyceryl Monostearate Peg-100 Stearate Allantoin .alpha.-tocopherol Acetate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Phenoxyethanol Ethylhexylglycerin Isohexadecane Polysorbate 80 Butylene Glycol Water Ethylhexyl Stearate Dimethicone Stearic Acid Medium-chain Triglycerides Cannabis Sativa Seed Oil Cetostearyl Alcohol Sunflower Oil Turmeric Glycerin Caprylyl Glycol Hexylene Glycol Sodium Hydroxide Edetate Disodium Anhydrous Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-21

Description

Lidocaine 4%

Purpose

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


Medication Information

Purpose

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

Description

Lidocaine 4%

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 50570-1

Do Not Use

  • in large quantities, particularly over raw surfaces or blistered areas
Section 51945-4

Hempvana

Ultra Strength

Pain Relief

Cream

Platinum

with 4% Lidocaine

+4xHemp Seed Oil for moisturization

Net Wt. 3 OZ (85 g)

Section 53414-9

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

Section 60561-8

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

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older:Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age:consult a physician
  • Apply generously to affected area.
  • Massage into painful area until thoroughly absorbed into skin.
  • Repeat as necessary, but no more than 4 times daily.
Questions?

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

Active Ingredient

Lidocaine 4%

Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Blue 1 (CI 42090), Yellow 5 (CI 19140)


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 50570-1 (50570-1)

Do Not Use

  • in large quantities, particularly over raw surfaces or blistered areas
Section 51945-4 (51945-4)

Hempvana

Ultra Strength

Pain Relief

Cream

Platinum

with 4% Lidocaine

+4xHemp Seed Oil for moisturization

Net Wt. 3 OZ (85 g)

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

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

Purpose

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

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older:Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age:consult a physician
  • Apply generously to affected area.
  • Massage into painful area until thoroughly absorbed into skin.
  • Repeat as necessary, but no more than 4 times daily.
Questions?

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

Active Ingredient

Lidocaine 4%

Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Blue 1 (CI 42090), Yellow 5 (CI 19140)


Advanced Ingredient Data


Raw Label Data

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