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

Purpose

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

Description

Lidocaine 4%


Medication Information

Warnings

For external use only

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.
  • 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.
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)

Description

Lidocaine 4%

Questions?

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 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.

Active Ingredient

Lidocaine 4%


Structured Label Content

Warnings

For external use only

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.
  • 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.
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)

Questions?

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 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.

Active Ingredient

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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