Lidocaine 4% Cream

Lidocaine 4% Cream
SPL v2
SPL
SPL Set ID e1a8d4a7-01f7-4bab-8d09-875c461b3b61
Route
TOPICAL
Published
Effective Date 2024-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Acrylamide Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Allantoin Aloe Vera Leaf Benzyl Alcohol Alkyl (c12-15) Benzoate 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 2024-02-15

Description

Drug Facts

Purpose

Local analgesic


Medication Information

Purpose

Local analgesic

Description

Drug Facts

Uses

for the temporary relief of pain and itching associated with

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Section 42229-5

Drug Facts

Section 50565-1

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

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.
Questions?

Call us at (800) 442-7882

Active Ingredient

Lidocaine 4% (4g in 100g)

Other Information

Store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients

acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.

When Using This Product
  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
If Pregnant Or Breast Feeding

Ask a health professional before use.

Stop Use and Consult A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel 28.35 G Tube Box

STRATUS

PHARMACEUTICALS INC

NDC 58980-824-30

Net WT. 1 oz. / 28.35 g

LIDOCAINE CREAM

4%

PAIN RELIEVING CREAM

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE


Structured Label Content

Uses

for the temporary relief of pain and itching associated with

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Local analgesic

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: do not use, consult a doctor.
Questions?

Call us at (800) 442-7882

Active Ingredient (Active ingredient)

Lidocaine 4% (4g in 100g)

Other Information (Other information)

Store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients (Inactive ingredients)

acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.

When Using This Product (When using this product)
  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Principal Display Panel 28.35 G Tube Box (PRINCIPAL DISPLAY PANEL - 28.35 g Tube Box)

STRATUS

PHARMACEUTICALS INC

NDC 58980-824-30

Net WT. 1 oz. / 28.35 g

LIDOCAINE CREAM

4%

PAIN RELIEVING CREAM

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE


Advanced Ingredient Data


Raw Label Data

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