84322-004

84322-004
SPL v1
SPL
SPL Set ID 1e5dbe37-302b-451f-e063-6294a90a6444
Route
TOPICAL
Published
Effective Date 2024-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Water Propylene Glycol Carbomer Homopolymer, Unspecified Type Glycerin Edetate Disodium 3'-hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-29

Description

Lidocaine 4%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine 4%

Use

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

Section 50565-1

In case of accidental ingestion, seek medical attention immediately.

Section 50566-9

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Section 50567-7

Do not exceed the recommended daily dosage unless 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 fingers or any medical

device or applicator.

Warnings

• For External Use Only

• Pregnant or breastfeeding, ask a health professional before use.

• In case of accidental overdose, contact a doctor or Poison Control Center immediately.

• Seal is broken or missing.

Directions

Perform a patch test on the back of your hand before using it to check for skin

sensitivity.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 up to 2 times a day.

Do Not Use

• Pregnant or breastfeeding, ask a health professional before use.

• In case of accidental overdose, contact a doctor or Poison Control Center immediately.

• Seal is broken or missing.

Other Information

Keep away from direct sunlight or heat

Store in room temperature (59-860F / 15-300C)

Active Ingredient(s)

Lidocaine 4%

Inactive Ingredients

WATER PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA. HYDROXY-ACETOPHENONE



Package Label Principal Display Panel


Structured Label Content

Use

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

Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical attention immediately.

Section 50566-9 (50566-9)

The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Section 50567-7 (50567-7)

Do not exceed the recommended daily dosage unless 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 fingers or any medical

device or applicator.

Purpose

External Analgesic

Warnings

• For External Use Only

• Pregnant or breastfeeding, ask a health professional before use.

• In case of accidental overdose, contact a doctor or Poison Control Center immediately.

• Seal is broken or missing.

Directions

Perform a patch test on the back of your hand before using it to check for skin

sensitivity.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 up to 2 times a day.

Do Not Use (Do not use)

• Pregnant or breastfeeding, ask a health professional before use.

• In case of accidental overdose, contact a doctor or Poison Control Center immediately.

• Seal is broken or missing.

Other Information (Other information)

Keep away from direct sunlight or heat

Store in room temperature (59-860F / 15-300C)

Active Ingredient(s)

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

WATER PROPYLENE GLYCOL, CARBOMER, GLYCERIN, DISODIUM EDTA. HYDROXY-ACETOPHENONE



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


Advanced Ingredient Data


Raw Label Data

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