82929-010-(01,02,03)

82929-010-(01,02,03)
SPL v1
SPL
SPL Set ID 0faaaa82-a06b-f9ca-e063-6294a90a150c
Route
cutaneous
Published
Effective Date 2024-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 g)
Inactive Ingredients
water carbomer homopolymer, unspecified type trolamine aloe vera whole propylene glycol menthol .alpha.-tocopherol acetate lecithin, soybean

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-24

Purpose

Topical Anesthetic

Description

Lidocaine 5%


Medication Information

Warnings

For external use only

Uses

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Purpose

Topical Anesthetic

Directions

Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thotoughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area uo to 6 times daily.

Inactive Ingredients

Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Carbomer, Menthol, Triethanolamine

Description

Lidocaine 5%

30ml / 1.06 Fl.oz

40ml / 1.41 Fl.oz

60ml / 2.12 Fl.oz

Other Informatiom

● Keep away from direct sunlight or heat

● Store in room temperature (59-86°F/15-30°C)

Active Ingredients

Lidocaine 5%

Do Not This Product

Pregnant or breastfeeding, ask a health professional before use.

When Using This Product

Do not exceed the recommended daily dosage unless directed by a doctor

Do not put into the rectum by using fingers or any mechanical device or applicator.

Stop Use and Ask A Doctor If

Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use

Keep Out of Reach of Children

In case of accidental ingestion, seek madical attention immediately


Structured Label Content

Warnings

For external use only

Uses

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.

Purpose

Topical Anesthetic

Directions

Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thotoughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area uo to 6 times daily.

Inactive Ingredients

Aloe barbadebsis leaf juice (Aloe vera), Water, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Carbomer, Menthol, Triethanolamine

30ml / 1.06 Fl.oz (30ml / 1.06 Fl.Oz)

40ml / 1.41 Fl.oz (40ml / 1.41 Fl.Oz)

60ml / 2.12 Fl.oz (60ml / 2.12 Fl.Oz)

Other Informatiom

● Keep away from direct sunlight or heat

● Store in room temperature (59-86°F/15-30°C)

Active Ingredients

Lidocaine 5%

Do Not This Product (Do not this product)

Pregnant or breastfeeding, ask a health professional before use.

When Using This Product (When using this product)

Do not exceed the recommended daily dosage unless directed by a doctor

Do not put into the rectum by using fingers or any mechanical device or applicator.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use

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

In case of accidental ingestion, seek madical attention immediately


Advanced Ingredient Data


Raw Label Data

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