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

Purpose

Local anesthetic

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses

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

Purpose

Local anesthetic

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.
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

Description

Drug Facts

Questions?

1-877-977-0687

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.
Active Ingredient

Lidocaine 5% w/w

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

Warnings

For external use only.

Uses

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

Purpose

Local anesthetic

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.
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

Questions?

1-877-977-0687

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.
Active Ingredient

Lidocaine 5% w/w

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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