INSECT STING RELIEF- benzocaine, alcohol swab 
GFA Production (Xiamen) 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 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 not finalpart34806/29/2018
Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
Establishment
NameAddressID/FEIBusiness Operations
GFA Production (Xiamen) Co., Ltd.421256261manufacture(50814-041)

Revised: 10/2019
Document Id: 951d34b0-6b6e-5132-e053-2a95a90aab55
Set id: 925e1d4c-6008-08da-e053-2995a90a6133
Version: 2
Effective Time: 20191017
 
GFA Production (Xiamen) Co., Ltd.