Bio-scriptives Lidum (lidocaine 5%) Hemorroidal (anorectal) Cream

Bio-scriptives Lidum (lidocaine 5%) Hemorroidal (anorectal) Cream
SPL v2
SPL
SPL Set ID 3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f03
Route
TOPICAL
Published
Effective Date 2012-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (2.8 g)
Inactive Ingredients
Aloe Vera Leaf Water Cholesterol Isopropyl Myristate Medium-chain Triglycerides Hydrogenated Soybean Lecithin Glyceryl Monostearate Polyethylene Glycol Arginine Hydrochloride Ethyl Oleate Propylene Glycol Tocophersolan Cetyl Alcohol Trolamine Xanthan Gum Alpha-tocopherol Allantoin Methylisothiazolinone Methyl Nicotinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-04

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Uses

■ For the temporary relief of local discomfort associated with anorectal disorders

■ For the temporary relief of pain, soreness, and burning.

Section 50565-1

Keep out of reach of children.

Warnings

For external use only.

When using this product ■ do not exceed the recommended daily dosage unless directed by a doctor.

do not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions

■ Children under 12 years of age: consult a doctor. ■ 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. Apply externally to the affected area up to 6 times daily.

Active Ingredient

Lidocaine 5%

Inactive Ingredients

Aloe, Water, Cholesterol, Isopropyl Mysristate, Aqua, Caprylic/Capric Triglyceride, Propylene Glycol, Hydrogenated Phosphatidylcholine, Glyceryl Stearate, PEG-100 Stearate, Arginine HCI, Ethyl Oleate, Propylene Glycol, Tocophersolan, Cetyl Alcohol, Triethanolamine, Xanthan Gum, Tocopherol, Allantoin, Aloe Barbadensis Leaf, Methylisothiazolinone, Methyl Nicotinate

Package and Lidum Images

+

Stop Use and Consult A Doctor If:

■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ allergic reaction occurs ■ redness, irritation, swelling, pain or other symptoms develop or increase


Structured Label Content

Uses

■ For the temporary relief of local discomfort associated with anorectal disorders

■ For the temporary relief of pain, soreness, and burning.

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Local Anesthetic

Warnings

For external use only.

When using this product ■ do not exceed the recommended daily dosage unless directed by a doctor.

do not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions

■ Children under 12 years of age: consult a doctor. ■ 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. Apply externally to the affected area up to 6 times daily.

Active Ingredient

Lidocaine 5%

Inactive Ingredients

Aloe, Water, Cholesterol, Isopropyl Mysristate, Aqua, Caprylic/Capric Triglyceride, Propylene Glycol, Hydrogenated Phosphatidylcholine, Glyceryl Stearate, PEG-100 Stearate, Arginine HCI, Ethyl Oleate, Propylene Glycol, Tocophersolan, Cetyl Alcohol, Triethanolamine, Xanthan Gum, Tocopherol, Allantoin, Aloe Barbadensis Leaf, Methylisothiazolinone, Methyl Nicotinate

Package and Lidum Images

+

Stop Use and Consult A Doctor If: (Stop use and consult a doctor if:)

■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ allergic reaction occurs ■ redness, irritation, swelling, pain or other symptoms develop or increase


Advanced Ingredient Data


Raw Label Data

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