SPL v2
SPL
SPL Set ID f435c3ed-f99b-4baf-af07-69780cd3ef9b
Route
TOPICAL
Published
Effective Date 2021-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (20 g)
Inactive Ingredients
Water Arnica Montana Flower C13-14 Isoparaffin Chondroitin Sulfate (bovine) Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Isopropyl Palmitate Laureth-7 Tea Tree Oil Dimethyl Sulfone Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-12-08

Description

Benzocaine 20% 

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Benzocaine 20% 

Uses

For temporary relief of pain and itching due to minor skin irritations.

Warnings

For external use only.

Avoid contact with eyes.

Do not use in large quantities, particularly over the raw surfaces or blistered area 

Stop use and ask a doctor if

condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times

daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Drug Facts

Product Label

Active Ingredient

Benzocaine 20% 

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate,

Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7,

Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,Polyacrylamide, Propylene Glycol,StearicAcid,Triethanolamine.

Questions Or Comments?
Keep Out of Reach of Children 

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


Structured Label Content

Uses

For temporary relief of pain and itching due to minor skin irritations.

Purpose

External Analgesic

Warnings (warnings)

For external use only.

Avoid contact with eyes.

Do not use in large quantities, particularly over the raw surfaces or blistered area 

Stop use and ask a doctor if

condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within the few days. Discontinue use.

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times

daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Benzocaine 20% 

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate,

Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7,

Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,Polyacrylamide, Propylene Glycol,StearicAcid,Triethanolamine.

Questions Or Comments? (Questions or comments?)
Keep Out of Reach of Children  (Keep out of reach of children )

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)