Hemorrhoid Pain Relief

Hemorrhoid Pain Relief
SPL v3
SPL
SPL Set ID 04164425-ca3b-ef24-e063-6294a90a59d8
Route
TOPICAL
Published
Effective Date 2023-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Hexylene Glycol Turmeric Allantoin Glycerin Sunflower Oil Stearic Acid Cannabis Sativa Seed Oil Peg-100 Stearate Dimethicone Phenoxyethanol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Ethylhexylglycerin Medium-chain Triglycerides .alpha.-tocopherol Acetate Glyceryl Monostearate Cetostearyl Alcohol Caprylyl Glycol Sodium Hydroxide Edetate Disodium Anhydrous Ethylhexyl Stearate Butylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-29

Description

Lidocaine 5%

Purpose

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


Medication Information

Purpose

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

Description

Lidocaine 5%

Uses

For the temporary relief of pain, burning, itching and discomfort associated with hemorrhoids.

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

  • if condition worsens or does not improve within 7 days
  • in case of bleeding
  • symptom being treated does not subside or if redness, irritation, swelling, 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

NDC 73287-028-01

Maximum OTC Strength

Hemorrhoid Pain Relief

Topical Anesthetic Cream

5% Lidocaine

+ Hemp Seed Oil For Moisturization

Net Wt. 3oz (85g)

100% Fragrance Free

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 Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, CetearylAlcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric)Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 AlkylAcrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,Hexylene Glycol, Sodium Hydroxide, Disodium EDTA


Structured Label Content

Uses

For the temporary relief of pain, burning, itching and discomfort associated with hemorrhoids.

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

  • if condition worsens or does not improve within 7 days
  • in case of bleeding
  • symptom being treated does not subside or if redness, irritation, swelling, 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

NDC 73287-028-01

Maximum OTC Strength

Hemorrhoid Pain Relief

Topical Anesthetic Cream

5% Lidocaine

+ Hemp Seed Oil For Moisturization

Net Wt. 3oz (85g)

100% Fragrance Free

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 Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, CetearylAlcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric)Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 AlkylAcrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,Hexylene Glycol, Sodium Hydroxide, Disodium EDTA


Advanced Ingredient Data


Raw Label Data

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