INSECT STING RELIEF- benzocaine swab

INSECT STING RELIEF by

Drug Labeling and Warnings

INSECT STING RELIEF by is a Otc medication manufactured, distributed, or labeled by GFA Production (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS - Insect Sting Relief Pad

Active Ingredient:

Benzocaine, 6% w/v

SD alcohol, 60% w/v 

Purpose:

Topical Anesthetic

Anesthetic

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 unsual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Contrl Center right away.

Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water

DOSAGE & ADMINISTRATION

Inactive Ingredients:

Purified water.

Package Labeling:

INGREDIENTS AND APPEARANCE

INSECT STING RELIEF 
benzocaine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50814-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	6 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-038-01	0.15 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	06/29/2018
2	NDC: 50814-038-02	1 g in 1 POUCH; Type 0: Not a Combination Product	06/29/2018	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/29/2018

Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)

Establishment
Name	Address	ID/FEI	Business Operations
GFA Production (Xiamen) Co., Ltd.		421256261	manufacture(50814-038)