Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 223bc4f5-e310-4de9-afa9-a7d79b19fa6d
Route
TOPICAL
Published
Effective Date 2019-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Allantoin Tricaprin Paprika Edetate Calcium Disodium Anhydrous Cannabis Sativa Seed Dimethicone .alpha.-tocopherol Acetate, Dl- Alcohol Ethylhexylglycerin Ethylhexyl Stearate Glycerin Phenoxyethanol Polysorbate 80 Propanediol Propylene Glycol Water Sodium Polyacrylate (2500000 Mw) Trideceth-6 Grape Seed Oil Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-09-18
Description

Lidocaine 4%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Lidocaine 4%

Uses

Temporarily relieves minor pain associated with:

.Arthritis         .Sprains            .Simple backache

.Bruises       .Muscle strains      .Cramps

Section 53413-1

Warnings

For external use only

Directions
  • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
  • Children under 12 years of age : Consult a doctor
Active Ingredient

Lidocaine 4%

Inactive Ingrdients

Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa Extract Oil, Dimethicone, dI-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Sterate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed oil, Xanthan Gum.

Principal Display Panel

NDC 73332-001-01

FOR EXTERNAL USE ONLY

CBD Pain Cream

+ Lidocaine

When Using This Product
  • Use only as directed, do not bandage tightly, avoid contact with eyes, do not apply to wounds or damaged skin, do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use and Ask A Doctor If
  • condition worsens, symptoms persist for more than 7 days or symptoms clear up and occur again within a few days.
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 minor pain associated with:

.Arthritis         .Sprains            .Simple backache

.Bruises       .Muscle strains      .Cramps

Section 53413-1 (53413-1)

Purpose

Topical analgesic

Warnings

For external use only

Directions
  • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
  • Children under 12 years of age : Consult a doctor
Active Ingredient

Lidocaine 4%

Inactive Ingrdients (Inactive ingrdients)

Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit Powder, Calcium Disodium EDTA, Cannabis Sativa Extract Oil, Dimethicone, dI-alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Sterate, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) Seed oil, Xanthan Gum.

Principal Display Panel

NDC 73332-001-01

FOR EXTERNAL USE ONLY

CBD Pain Cream

+ Lidocaine

When Using This Product (When using this product)
  • Use only as directed, do not bandage tightly, avoid contact with eyes, do not apply to wounds or damaged skin, do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, symptoms persist for more than 7 days or symptoms clear up and occur again within a few days.
Keep Out of Reach of Children (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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:52.958596 · Updated: 2026-03-14T22:55:39.728866