Lidocaine 5%

Lidocaine 5%
SPL v3
SPL
SPL Set ID 47eb3395-ca44-47bd-80ce-9a31ac392a04
Route
TOPICAL
Published
Effective Date 2020-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Medium-chain Triglycerides Cholesterol Lecithin, Soybean Isopropyl Myristate Polysorbate 80 Propylene Glycol Tocopherol Trolamine Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-12-15

Description

Drug Facts

Purpose

Local anesthetic


Medication Information

Purpose

Local anesthetic

Description

Drug Facts

Uses

Helps relieve the pain, itching, and burningassociated with hemorrhoids and other anorectal disorders.

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.
Warnings

For external use only.

Directions
  • 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 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.
Questions?

1-877-977-0687

Active Ingredient

Lidocaine 5% w/w

Other Information

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

Inactive Ingredients

benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water

Stop Use and Ask A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Principal Display Panel 30 G Tube Carton

NDC 75834-113-30

Lidocaine 5%

Anorectal Cream

Relieves:

  • Pain
  • Itching
  • Burning

NIVAGEN

PHARMACEUTICALS

net wt. 30 g (1 oz)


Structured Label Content

Uses

Helps relieve the pain, itching, and burningassociated with hemorrhoids and other anorectal disorders.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.
Purpose

Local anesthetic

Warnings

For external use only.

Directions
  • 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 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.
Questions?

1-877-977-0687

Active Ingredient

Lidocaine 5% w/w

Other Information

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

Inactive Ingredients

benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Principal Display Panel 30 G Tube Carton (PRINCIPAL DISPLAY PANEL - 30 g Tube Carton)

NDC 75834-113-30

Lidocaine 5%

Anorectal Cream

Relieves:

  • Pain
  • Itching
  • Burning

NIVAGEN

PHARMACEUTICALS

net wt. 30 g (1 oz)


Advanced Ingredient Data


Raw Label Data

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