Topicaine

Topicaine
SPL v4
SPL
SPL Set ID 7f96e980-891e-743d-e053-2a91aa0aea5f
Route
TOPICAL
Published
Effective Date 2003-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (44.534 g)
Inactive Ingredients
Water Carbomer 940 Alcohol Jojoba Oil Glyceryl Laurate Aloe Vera Leaf Benzyl Alcohol Glycerin Edetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-04-20
Description

Lidocaine 4% w/w

Purpose

Topical Anesthetic

Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4% w/w

Uses

For the temporary relief of pain.

Warnings

For external use only

Flammable

Keep away from sparks, heat and fire. Cap tube tightly when not in use.

Questions

Call toll-free in USA & Canada 800-677-9299 or visit www.topicaine.com

Directions

Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.

Active Ingredient

Lidocaine 4% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

Stop Use and Ask A Doctor If:
  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • you notice any unusual effects
Keep Out of the Reach of Children

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

Labelling On Tubes and Outer Cartons

Labelling printed on tube of Topicaine 4% 10 gram tube:

Outer carton of Topicaine 4% 10 grams:

Label affixed to Topicaine 4% 30 gram tubes:

Outer box of Topicaine 4% 30 grams:

Label affixed to tubes of Topicaine 4% 113 grams:

Structured Label Content

Uses

For the temporary relief of pain.

Purpose

Topical Anesthetic

Warnings

For external use only

Flammable

Keep away from sparks, heat and fire. Cap tube tightly when not in use.

Questions

Call toll-free in USA & Canada 800-677-9299 or visit www.topicaine.com

Directions

Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.

Active Ingredient (Active ingredient)

Lidocaine 4% w/w

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • you notice any unusual effects
Keep Out of the Reach of Children (Keep out of the reach of children)

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

Labelling On Tubes and Outer Cartons (Labelling on tubes and outer cartons)

Labelling printed on tube of Topicaine 4% 10 gram tube:

Outer carton of Topicaine 4% 10 grams:

Label affixed to Topicaine 4% 30 gram tubes:

Outer box of Topicaine 4% 30 grams:

Label affixed to tubes of Topicaine 4% 113 grams:

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:36.583075 · Updated: 2026-03-14T23:03:47.044278