SPL v3
SPL
SPL Set ID 827fec2f-db3c-adbb-e053-2a91aa0a7c17
Route
TOPICAL
Published
Effective Date 2019-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (3.9 g)
Inactive Ingredients
Aloe Glycerin Stearic Acid Glyceryl Stearate Se Isopropyl Myristate Diethylene Glycol Monoethyl Ether Ceresin Polysorbate 80 Carboxypolymethylene Zinc Oxide Allantoin Ascorbic Acid Methylparaben Diazolidinyl Urea Propylparaben Trolamine Edetate Sodium .alpha.-tocopherol Acetate Almond Oil Canola Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-15

Description

Lidocaine - 3.9%

Purpose

Topical Pain Reliever


Medication Information

Purpose

Topical Pain Reliever

Description

Lidocaine - 3.9%

Uses

Temporarily relieves pain due to:

  • burns
  • insect bites
  • itching
Section 51945-4

Warnings

For external use only.

Do not use in large quantities, particularity over raw surfaces or blistered areas.

When using this product keep out of eyes, use only as directed.

Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

Directions

Adults and children 5 years of age and older: apply to affected area not more that 3-4 times daily. Children under 5 years of age: ask a doctor.

Active Ingredient

Lidocaine - 3.9%





Inactive Ingredients

Aloe Barbadensis Leaf Juice, Glycerin, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Canola Oil, Fragrance.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Temporarily relieves pain due to:

  • burns
  • insect bites
  • itching
Section 51945-4 (51945-4)

Purpose

Topical Pain Reliever

Warnings

For external use only.

Do not use in large quantities, particularity over raw surfaces or blistered areas.

When using this product keep out of eyes, use only as directed.

Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

Directions

Adults and children 5 years of age and older: apply to affected area not more that 3-4 times daily. Children under 5 years of age: ask a doctor.

Active Ingredient (Active ingredient)

Lidocaine - 3.9%





Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Glycerin, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Canola Oil, Fragrance.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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