20% Benzocaine Gel

20% Benzocaine Gel
SPL v3
SPL
SPL Set ID 60cafbaf-8ec6-46a5-e053-2a91aa0af11f
Route
TOPICAL
Published
Effective Date 2017-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg)
Inactive Ingredients
Polyethylene Glycol 400 Sorbic Acid Phenoxyethanol Caprylyl Glycol Alcohol Water Carboxypolymethylene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-01

Description

Benzocaine 20%


Medication Information

Warnings and Precautions

For external use only. Avoid contact with the eyes.

Stop use and ask a doctor if:

  • Skin becomes irritated
  • Condition worsens or symptoms last more than 7 days
  • Symptoms clear up and reoccur within a few days

DO NOT USE: in large quantities, particularly over raw surfaces or blistered areas.

Indications and Usage

USES: For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

Dosage and Administration

USES: For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

Description

Benzocaine 20%

Section 50565-1

Keep out of reach of children.

Section 51727-6

EthylAlcohol, PEG-8, Purified Water, Carbomer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Benzocaine 20%


Structured Label Content

Indications and Usage (34067-9)

USES: For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

Dosage and Administration (34068-7)

USES: For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

DIRECTIONS: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily.

Warnings and Precautions (34071-1)

For external use only. Avoid contact with the eyes.

Stop use and ask a doctor if:

  • Skin becomes irritated
  • Condition worsens or symptoms last more than 7 days
  • Symptoms clear up and reoccur within a few days

DO NOT USE: in large quantities, particularly over raw surfaces or blistered areas.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

EthylAlcohol, PEG-8, Purified Water, Carbomer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Benzocaine 20%


Advanced Ingredient Data


Raw Label Data

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