61333-215 Light Instant Sting Relief Pad

61333-215 Light Instant Sting Relief Pad
SPL v3
SPL
SPL Set ID 28dd82a7-f360-a022-e063-6394a90a3a76
Route
TOPICAL
Published
Effective Date 2024-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (6 g) Isopropyl Alcohol (65.4 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-06

Description

Benzocaine 6% w/v Isopropyl Alcohol: 65.4% v/v

Purpose

Topical Anesthetic Antiseptic


Medication Information

Warnings and Precautions

Warnings:

For external use only. Flammable, keep away from fire or flame. Avoid contact with eyes, if this happens, rinse throughly with water. DO NOT USE with electrocautery procedures.

Indications and Usage

Uses: For temporary relief of pain and itching associated with minor burns, sunburns, minor cut, scrapes, insect bites, or minor skin irritations

Purpose

Topical Anesthetic

Antiseptic

Description

Benzocaine 6% w/v Isopropyl Alcohol: 65.4% v/v

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if

  • irritation or redness develops
  • if condition worsens or persists for more than 7 days, or clear up and occur again within a few days, consult a physician
Section 51727-6

Inactive Ingredient

Purified Water

Section 51945-4

Directions

For adults and children 2 yeas of age or older: Apply to affected area not more than 3-4 times daily

Children under 2 yeas of age: Consult a doctor before use

Active Ingredient

Benzocaine 6% w/v

Isopropyl Alcohol: 65.4% v/v

Other Information

Store at room temperature 15-30 C (59-86F). Avoid excessive heat.


Structured Label Content

Indications and Usage (34067-9)

Uses: For temporary relief of pain and itching associated with minor burns, sunburns, minor cut, scrapes, insect bites, or minor skin irritations

Warnings and Precautions (34071-1)

Warnings:

For external use only. Flammable, keep away from fire or flame. Avoid contact with eyes, if this happens, rinse throughly with water. DO NOT USE with electrocautery procedures.

Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • irritation or redness develops
  • if condition worsens or persists for more than 7 days, or clear up and occur again within a few days, consult a physician
Section 51727-6 (51727-6)

Inactive Ingredient

Purified Water

Section 51945-4 (51945-4)

Purpose

Topical Anesthetic

Antiseptic

Directions

For adults and children 2 yeas of age or older: Apply to affected area not more than 3-4 times daily

Children under 2 yeas of age: Consult a doctor before use

Active Ingredient

Benzocaine 6% w/v

Isopropyl Alcohol: 65.4% v/v

Other Information

Store at room temperature 15-30 C (59-86F). Avoid excessive heat.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)