INSECT STING RELIEF- benzocaine, alcohol 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, alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-041
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE60 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL600 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-041-010.18 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/29/2018
2NDC:50814-041-020.53 mL in 1 POUCH; Type 0: Not a Combination Product06/29/2018
3NDC:50814-041-030.225 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/2019
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(50814-041)

Revised: 10/2023
Document Id: 0888f7db-5b64-d846-e063-6394a90ac05b
Set id: 925e1d4c-6008-08da-e053-2995a90a6133
Version: 4
Effective Time: 20231025
 
GFA Production (Xiamen) Co., Ltd.