Hempvana Topical Anesthetic Cream

Hempvana Topical Anesthetic Cream
SPL v2
SPL
SPL Set ID f525075a-d7ee-dad0-e053-2a95a90a6f3f
Route
TOPICAL
Published
Effective Date 2023-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Cannabis Sativa Seed Oil .alpha.-tocopherol Acetate Turmeric Glyceryl Monostearate Peg-100 Stearate Caprylyl Glycol Phenoxyethanol Ethylhexylglycerin Medium-chain Triglycerides Glycerin Cetostearyl Alcohol Allantoin Butylene Glycol Sodium Hydroxide Edetate Disodium Anhydrous Sunflower Seed Water Stearic Acid Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Ethylhexyl Stearate Hexylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-17

Description

Lidocaine 5%

Purpose

Lidocaine 5%...........Local Anesthetic


Medication Information

Purpose

Lidocaine 5%...........Local Anesthetic

Description

Lidocaine 5%

Uses

For the temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation.

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 or does not improve within 7 days
  • in case of bleeding
  • symptom being treated does not subside or if redness, irritation, sweeling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product.
Section 50567-7

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor.
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not put this product into the rectum by using finger or any mechanical device or applicator.
Section 51945-4

Hempvana

Maximum Strength Pain Relief Topical Anesthetic Cream

5% Lidocaine anorectal cream

+Hemp Seed Oil For Moisturization

Odor Free!

Net Wt. 3 oz (85 g)

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:When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product to affected area.
  • Apply to the affected area up to 6 times a day
  • Children under 12 years of age:consult a doctor.
Questions?

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

Active Ingredient

Lidocaine 5%

Other Information
  • Do not use if seal is broken or missing
Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Saliva (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


Structured Label Content

Uses

For the temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation.

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 or does not improve within 7 days
  • in case of bleeding
  • symptom being treated does not subside or if redness, irritation, sweeling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product.
Section 50567-7 (50567-7)

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor.
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not put this product into the rectum by using finger or any mechanical device or applicator.
Section 51945-4 (51945-4)

Hempvana

Maximum Strength Pain Relief Topical Anesthetic Cream

5% Lidocaine anorectal cream

+Hemp Seed Oil For Moisturization

Odor Free!

Net Wt. 3 oz (85 g)

Section 53414-9 (53414-9)

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

Purpose

Lidocaine 5%...........Local Anesthetic

Warnings

For external use only

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

Directions
  • Adults:When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product to affected area.
  • Apply to the affected area up to 6 times a day
  • Children under 12 years of age:consult a doctor.
Questions?

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

Active Ingredient (Active ingredient)

Lidocaine 5%

Other Information (Other information)
  • Do not use if seal is broken or missing
Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Saliva (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


Advanced Ingredient Data


Raw Label Data

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