Lidocaine 5% Cream

Lidocaine 5% Cream
SPL v5
SPL
SPL Set ID 87a4f559-a4f6-4b9f-98de-b55b073a11c6
Route
TOPICAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Acrylamide Allantoin Aloe Vera Leaf Benzyl Alcohol Alkyl (c12-15) Benzoate Carbomer Homopolymer, Unspecified Type Isohexadecane Polysorbate 80 Propylene Glycol Water Sodium Acryloyldimethyltaurate Sodium Laureth-3 Sulfate Soybean Lecithin .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-12

Description

Drug Facts

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Drug Facts

Uses

Helps relieve the pain, itching, and burning associated with other rectal disorders.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of of children. If swallowed, get medical help or contact Poison Control Center immediately.

Warnings

"Methemoglobinemia Warning" use of this product may cause; a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used the product before. Stop use and seek immediate medical attention if the following develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. If pregnant or breast feeding, ask a health provider before use.

Directions

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Active Ingredient

Lidocaine 5% w/w

Other Information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

acrylamide, allantoin, aloe vera extract, benzyl alcohol, C12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloyldimethyl taurate, sodium laureth sulfate, soy lecithin and tocopheryl acetate.

Principal Display Panel 14.17 G Tube Box

STRATUS

PHARMACEUTICALS INC

NDC 58980-823-05

Net WT. 0.5 oz. / 14.17 g

LIDOCAINE CREAM

5%

ANORECTAL CREAM


Structured Label Content

Uses

Helps relieve the pain, itching, and burning associated with other rectal disorders.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of of children. If swallowed, get medical help or contact Poison Control Center immediately.

Purpose

Local anesthetic

Warnings (WARNINGS)

"Methemoglobinemia Warning" use of this product may cause; a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used the product before. Stop use and seek immediate medical attention if the following develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. If pregnant or breast feeding, ask a health provider before use.

Directions

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Active Ingredient

Lidocaine 5% w/w

Other Information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

acrylamide, allantoin, aloe vera extract, benzyl alcohol, C12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloyldimethyl taurate, sodium laureth sulfate, soy lecithin and tocopheryl acetate.

Principal Display Panel 14.17 G Tube Box (PRINCIPAL DISPLAY PANEL - 14.17 g Tube Box)

STRATUS

PHARMACEUTICALS INC

NDC 58980-823-05

Net WT. 0.5 oz. / 14.17 g

LIDOCAINE CREAM

5%

ANORECTAL CREAM


Advanced Ingredient Data


Raw Label Data

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