81799-008

81799-008
SPL v1
SPL
SPL Set ID f4be3cb8-7015-1b65-e053-2995a90a3955
Route
TOPICAL
Published
Effective Date 2023-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 mg)
Inactive Ingredients
Benzyl Alcohol Water Carboxypolymethylene Propylene Glycol .alpha.-tocopherol Acetate, Dl- Lecithin, Soybean

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-02-15

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Use

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

Section 50565-1

Adults: When practical, cleanse the affected area with mild soap

and warm water and rise thoroughly.

Gently dry by patting with toilet tissue or a soft cloth, before

application of this product.

Apply up to 6 times a day.

Children under 12 years of age: consult a doctor

Section 50566-9

the symptom being treated does not subside, or if redness

Section 50567-7

directed by a doctor.

certain persons can develop allergic reactions to ingredients

in this product.

do not put this product into the rectum by using finger or

any medical device or applicator

Section 50569-3

irritation, swelling, pain, or other symptoms develop or increase

Section 53413-1
Warnings

For external use only

Directions

Adults: When practical, cleanse the affected area with mild soap

and warm water and rise thoroughly.

Gently dry by patting with toilet tissue or a soft cloth, before

application of this product.

Apply up to 6 times a day.

Children under 12 years of age: consult a doctor

Do Not Use

Pregnant or breastfeeding, ask a health professional before use.

In case of accidental overdose, get medical help or contact the

Poison Control Center immediately.

Seal is broken or missing

Other Information

Keep away from direct sunlight or heat.

Store at room tempetature 15°-30°C (59°-86°F)

Active Ingredient(s)

Lidocaine 5%

Inactive Ingredients

Carbomer 934, Emu Oil, Arnica, Lecithin(Soybean), Propylene

Glycol, Tocopheryl Acetate, Benzyl Alcohol, Water

Package Label Principal Display Panel

81799-008-01 1

81799-008-01 2


Structured Label Content

Use

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

Section 50565-1 (50565-1)

Adults: When practical, cleanse the affected area with mild soap

and warm water and rise thoroughly.

Gently dry by patting with toilet tissue or a soft cloth, before

application of this product.

Apply up to 6 times a day.

Children under 12 years of age: consult a doctor

Section 50566-9 (50566-9)

the symptom being treated does not subside, or if redness

Section 50567-7 (50567-7)

directed by a doctor.

certain persons can develop allergic reactions to ingredients

in this product.

do not put this product into the rectum by using finger or

any medical device or applicator

Section 50569-3 (50569-3)

irritation, swelling, pain, or other symptoms develop or increase

Section 53413-1 (53413-1)
Purpose

Local Anesthetic

Warnings

For external use only

Directions

Adults: When practical, cleanse the affected area with mild soap

and warm water and rise thoroughly.

Gently dry by patting with toilet tissue or a soft cloth, before

application of this product.

Apply up to 6 times a day.

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

Pregnant or breastfeeding, ask a health professional before use.

In case of accidental overdose, get medical help or contact the

Poison Control Center immediately.

Seal is broken or missing

Other Information (Other information)

Keep away from direct sunlight or heat.

Store at room tempetature 15°-30°C (59°-86°F)

Active Ingredient(s)

Lidocaine 5%

Inactive Ingredients (Inactive ingredients)

Carbomer 934, Emu Oil, Arnica, Lecithin(Soybean), Propylene

Glycol, Tocopheryl Acetate, Benzyl Alcohol, Water

Package Label Principal Display Panel (Package Label - Principal Display Panel)

81799-008-01 1

81799-008-01 2


Advanced Ingredient Data


Raw Label Data

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