INSECT STING RELIEF- benzocaine swab 
GFA Production (Xiamen) Co., Ltd.

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INSECT STING RELIEF PAD

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

Inactive Ingredients:

Purified water.

Package Labeling:

Label

INSECT STING RELIEF 
benzocaine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-038-010.15 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/29/2018
2NDC:50814-038-021 g in 1 POUCH; Type 0: Not a Combination Product06/29/201812/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/29/2018
Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
Establishment
NameAddressID/FEIBusiness Operations
GFA Production (Xiamen) Co., Ltd.421256261manufacture(50814-038)

Revised: 10/2023
Document Id: 0888f7db-5b58-d846-e063-6394a90ac05b
Set id: 6fc709f5-66e1-243e-e053-2991aa0a3c5d
Version: 5
Effective Time: 20231025
 
GFA Production (Xiamen) Co., Ltd.