20/20 Topical Anesthetic Strip

20/20 Topical Anesthetic Strip
SPL v2
SPL
SPL Set ID 0584e235-34f8-4d53-aa7c-ac11e01ac456
Route
DENTAL
Published
Effective Date 2012-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (10 mg)
Inactive Ingredients
Hypromellose 2208 (3 Mpa.s) Hypromellose 2208 (100 Mpa.s) Hypromellose 2208 (4000 Mpa.s) Glycerin Peppermint Oil Acacia Carboxymethylcellulose Sodium Sucralose Polysorbate 80 Sodium Copper Chlorophyllin

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-02-28

Description

Drug Facts

Purpose

Oral pain reliever


Medication Information

Purpose

Oral pain reliever

Description

Drug Facts

Use

Temporary relief of oral pain

Other

Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHT

Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

This carrying case may present a choking hazard. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Section 50568-5

Consult a physician or qualified health care professional prior to using this product if you have any medical conditions, or if you are using any prescription drug.

Directions

Not for use by individuals under 12 years of age.

Dosage: 1 strip, not more than 4 per day

  • Remove 1 strip from carrying case.
  • Place strip onto area of desired anesthesia
  • Allow strip to dissolve completely
Allergy Alert

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Active Ingredient

Benzocaine 20%

Inactive Ingredients

Hydroxypropyl Methyl Cellulose, Gylcerine, Peppermint Oil Flavor, Gum Arabic, Sodium Carboxy Methyl Cellulose, Sucralose, Polysorbate 80, Sodium Copper Chlorophyllin.

Stop Use and Ask Doctor If
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
Principal Display Panel 24 Strip Pouch Label

Active Ingredient: Benzocaine 20%

20/20

Topical Anesthetic Strip

24 STRIPS


Structured Label Content

Use

Temporary relief of oral pain

Other

Storage conditions: 55° to 78° Fahrenheit in a dry place. Keep foil pouch for information. KEEP AWAY FROM LIGHT

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

This carrying case may present a choking hazard. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Section 50568-5 (50568-5)

Consult a physician or qualified health care professional prior to using this product if you have any medical conditions, or if you are using any prescription drug.

Purpose

Oral pain reliever

Directions

Not for use by individuals under 12 years of age.

Dosage: 1 strip, not more than 4 per day

  • Remove 1 strip from carrying case.
  • Place strip onto area of desired anesthesia
  • Allow strip to dissolve completely
Allergy Alert (Allergy alert)

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

Active Ingredient (Active ingredient)

Benzocaine 20%

Inactive Ingredients (Inactive ingredients)

Hydroxypropyl Methyl Cellulose, Gylcerine, Peppermint Oil Flavor, Gum Arabic, Sodium Carboxy Methyl Cellulose, Sucralose, Polysorbate 80, Sodium Copper Chlorophyllin.

Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
Principal Display Panel 24 Strip Pouch Label (PRINCIPAL DISPLAY PANEL - 24 Strip Pouch Label)

Active Ingredient: Benzocaine 20%

20/20

Topical Anesthetic Strip

24 STRIPS


Advanced Ingredient Data


Raw Label Data

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