Puregen Labs Maximum Strength Lidocaine 5% Cream

Puregen Labs Maximum Strength Lidocaine 5% Cream
SPL v1
SPL
SPL Set ID f4f89582-49e6-424a-bea7-0694484a7c99
Route
TOPICAL
Published
Effective Date 2024-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Water Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Dimethyl Isosorbide Ethylhexylglycerin Ethylhexyl Stearate Phenoxyethanol Propylene Glycol Edetate Sodium .alpha.-tocopherol Acetate Trideceth-6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-22

Description

Lidocaine 5.00 %

Purpose

Anorectal (hemorrhoidal)


Medication Information

Purpose

Anorectal (hemorrhoidal)

Description

Lidocaine 5.00 %

Uses
  • Helps relieve the local itching and discomfort in the perianal area 
  • For the temporary relief of pain, irritation” or burning.
Do Not
  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using fingers or any mechanical device or applicator.
Warnings:

For external use only

Drug Facts

Questions?

call toll-free 1-800-630-8895

Directions:

Adults:

  • When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad 
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
  • Children under 12 years of age: consult a doctor. 
  • Apply externally to the affected area up to 6 times daily or after each bowel movement.
Package Labeling:

Active Ingredients

Lidocaine 5.00 %

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Ethylhexylglycerin, Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6

When Using This Product
  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.
Stop Use and Ask A Doctor If
  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Allergy alert 

  • Certain persons can develop allergic reactions to ingredients in this product.
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • Helps relieve the local itching and discomfort in the perianal area 
  • For the temporary relief of pain, irritation” or burning.
Do Not (Do not)
  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using fingers or any mechanical device or applicator.
Purpose

Anorectal (hemorrhoidal)

Warnings:

For external use only

Drug Facts

Questions?

call toll-free 1-800-630-8895

Directions:

Adults:

  • When practical, cleanse the affected area “with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad 
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
  • Children under 12 years of age: consult a doctor. 
  • Apply externally to the affected area up to 6 times daily or after each bowel movement.
Package Labeling:

Active Ingredients (Active ingredients)

Lidocaine 5.00 %

Other Information: (Other information:)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Ethylhexylglycerin, Ethylhexyl Stearate, Hydrogenated Polyisobutene, Lecithin, Phenoxyethanol, Propylene Glycol, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trideceth-6

When Using This Product (When using this product)
  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Allergy alert 

  • Certain persons can develop allergic reactions to ingredients in this product.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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