DRUG FACTS

Active ingredients

Benzocaine, 6% w/v

SD alcohol, 60% w/v

Purpose

Topical Anesthetic`

Antiseptic

Use:

For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings:

For external use only.

Do not use:

In eyes, on broken skin, deep puncture wounds. If unusual redness, swelling, irritation or other'symptoms occur, consult a physician immediately.

Keep out of reach of children.

If swallowed, get medical Thelp or contact a Poison Control Center right away.Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water.

Directions:

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a doctor.

Inactive ingredients

Purified water.

Package Labeling:

Label

INSECT STING RELIEF
benzocaine, alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83165-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	60 mg in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	600 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83165-003-00	0.62 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	01/14/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/14/2023

Labeler - Hubei Fanjian Medical Product Co.,Ltd (846385590)

Name	Address	ID/FEI	Business Operations
Establishment
Hubei Fanjian Medical Product Co.,Ltd		846385590	manufacture(83165-003)

Insect Sting Relief