INSECT STING RELIEF- benzocaine, alcohol cloth
Hubei Fanjian Medical Product Co.,Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Insect Sting Relief

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 not final	part348	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)

Revised: 5/2023

Document Id: fc19c4eb-9dba-7a9c-e053-6394a90adc45

Set id: f30401c1-961e-44dd-e053-2a95a90a69d6

Version: 2

Effective Time: 20230520

Hubei Fanjian Medical Product Co.,Ltd